Cranial/ENT 3.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 04056481132439), received between Mar 19, 2018 and Jun 10, 2026 — classified as 101 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (103 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K092467, K192703); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 31, 2020Terminated

   Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.

   Z-0056-2021 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Use of Device Problem

  A CRANIAL SURGERY FOR STEREOELECTROENCEPHALOGRAPHY (SEEG) DEPTH ELECTRODE PLACEMENTS IN THE BRAIN, INTO THE LEFT LINGUAL GYRUS, TO DETERMINE THE SOURCE OF SEIZURES, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. FROM A POST-OPERATIVE CT SCAN, THE SURGEON DETERMINED ON THE DAY OF THE PLANNED FOLLOW-UP RESECTION SURGERY, THAT ONE OF THE ELECTRODES PLACED, THE POSTERIOR MARGIN ELECTRODE, HAD DEVIATED FROM THE INTENDED TRAJECTORY BY CA. 10MM AT ITS TARGET AND ANGULATED BY CA. 16°. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH THE ELECTRODE READINGS AS DESIRED TO RETRIEVE THE INFORMATION NEEDED, WITHOUT ANY CHANGES TO THE PLANNED PROCEDURE. - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENT, AND THERE WAS NO SURGERY/ANESTHESIA PROLONGATION. - THERE WERE NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. HOSPITALIZATION WAS ALSO NOT PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456680 ↗
• InjuryJun 3, 2026Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A CATHETER PLACEMENT IN THE BRAIN, FOR DRAINAGE OF CEREBROSPINAL FLUID (CSF), FOLLOWED BY A BRAIN TUMOR RESECTION, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. AFTER TWO NAVIGATED CATHETER PLACEMENT ATTEMPTS, WITHOUT RETRIEVING THE EXPECTED CSF, THE SURGEON DETERMINED THAT THESE HAD MISSED THE VENTRICLE AND HAD DEVIATED FROM THE INTENDED PATH. THE SURGEON PLACED THE DRAINAGE CATHETER FREEHANDED INSTEAD AT THIS SURGERY. AFTERWARDS, THE USER DETERMINED THAT THE NAVIGATION ACCURACY HAD DETERIORATED. THE OR TEAM UNDRAPED THE PATIENT AND RE-REGISTERED THE PATIENT ANATOMY LOCATION TO THE NAVIGATION SUCCESSFULLY FOR THE PLANNED TUMOR RESECTION PART OF THIS SURGERY, WITH THE NAVIGATION REMAINING AS ACCURATE AS DESIRED FOR THE REMAINDER OF THE SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITHOUT ANY FURTHER CHANGES TO THE PLANNED PROCEDURE. THERE WAS NO (DIRECT OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING CATHETER PLACEMENT ATTEMPTS. THERE WAS NO RESULTING HARM OR NEGATIVE EFFECT TO THE PATIENT, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25372040 ↗
• InjuryMar 4, 2026Use of Device Problem; Improper or Incorrect Procedure or Method

  CRANIAL SURGERY FOR A DIAGNOSTIC BIOPSY OF A FUSIFORM GYRUS LESION REGION (5CM IN DEPTH, 0,6ML IN SIZE) WAS PERFORMED WITH THE AID OF BRAINLAB CRANIAL NAVIGATION (CRANIAL/ ENT 3.1) A TRAJECTORY WAS PLANNED BEFORE THE SURGERY ON PRE-OPERATIVE MRI SCANS ACQUIRED FOR THIS PATIENT. FOUR BIOPSY PASSES WERE INTENDED AND EXECUTED USING A NAVIGATED THIRD-PARTY BIOPSY NEEDLE. THE INITIAL HISTOLOGY WAS NON-TUMOROUS SUGGESTING SAMPLING OUTSIDE THE INTENDED BRAINLAB GUIDED TRAJECTORY, CONFIRMED BY POST OPERATIVE CT IMAGING DEMONSTRATING THAT THE BIOPSY TRAJECTORY DEVIATED MEDIALLY AND POSTERIORLY (5-6 MM AT THE ENTRY POINT AND 2-3 MM AT THE TARGET). ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE PURPOSE OF THE SURGERY WAS TO ONLY RECEIVE DIAGNOSTIC SAMPLES AND NOT TO REMOVE THE LESION AND/OR TREAT THE DISEASE. THE DEVIATION OF THE ACTUAL BIOPSY PATH PERFORMED IN THE BRAIN FROM THE INTENDED TRAJECTORY WAS DETECTED AFTER THE SURGERY, FOLLOWING NEGATIVE HISTOLOGICAL RESULTS. THE PATIENT EXPERIENCED MINOR LOSS OF VISION ON THE LEFT EYE DUE TO THE DEVIATING SURGICAL ACTIONS PERFORMED IN THE BRAIN WITH THE AID OF NAVIGATION. THE EFFECT PERSISTS (ALTHOUGH IMPROVING) AT THE CURRENT POINT IN TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Eye / Vision Problem

  MAUDE report 24504589 ↗
• InjuryNov 27, 2025Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR AN ABLATION OF A LESION, LOCATED UP TO CA. 20MM DEEP RIGHT PARIETAL IN THE BRAIN, WITH A SIZE OF CA. 3CCM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. PLACEMENT OF ONE LASER FIBER WAS INTENDED. AFTER PLACING THE LASER FIBER, THE SURGEONS DETECTED FROM A PRE-ABLATION MRI SCAN, THAT THE LASER FIBER PATH AND TARGET POINT WAS DEVIATING SHIFTED BY CA. 8MM ANTERIORLY AND LATERALLY FROM ITS INTENDED/PLANNED LOCATION. THE SURGEONS DECIDED TO REMOVE THE LASER FIBER AND TO RE-PLACE IT TO A NEW APPROACH WITH A NEW SKULL BURR HOLE AT THE SAME SURGERY, WITH NAVIGATION, RESULTING IN A SUCCESSFUL LASER ABLATION OF THE LESION AS DESIRED. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENTS, ALSO NOT DUE TO THE PROLONGATION OF THE SURGERY/ANESTHESIA BY CA. 30MIN. THERE WERE FURTHER NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. HOSPITALIZATION WAS ALSO NOT PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23664882 ↗
• InjuryNov 24, 2025Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR AN ABLATION OF A LESION, LOCATED UP TO CA. 40MM DEEP LEFT FRONTAL IN THE BRAIN, WITH A SIZE OF CA. 17CCM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. PLACEMENT OF ONE LASER FIBER WAS INTENDED, WITH A NAVIGATED BIOPSY OF THE TUMOR BEFOREHAND WITH 1 PASS WITHIN THE SAME PATH. AFTER PERFORMING THE BIOPSY SUCCESSFULLY WITH THE DESIRED DIAGNOSTIC SAMPLE RETRIEVED, AND PLACING THE LASER FIBER, THE SURGEONS DETECTED FROM A PRE-ABLATION MRI SCAN, THAT THE LASER FIBER PATH AND TARGET POINT WAS DEVIATING SHIFTED BY CA. 6MM POSTERIORLY FROM ITS INTENDED/PLANNED LOCATION, ALTHOUGH STILL IN THE LESION. CORRESPONDINGLY, THE BIOPSY PATH AND TARGET HAD DEVIATED IN THE SAME WAY. THE SURGEONS DECIDED TO REMOVE THE LASER FIBER AND TO RE-PLACE IT TO A NEW APPROACH WITH A NEW SKULL BURR HOLE AT THE SAME SURGERY, WITH NAVIGATION, RESULTING IN A SUCCESSFUL LASER ABLATION OF THE LESION AS DESIRED. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE BEFOREHAND BIOPSY AT THIS SURGERY WAS SUCCESSFUL AS INTENDED, WITH THE DIAGNOSTIC SAMPLE RETRIEVED AS DESIRED. THERE WAS NO DIRECT (OR INCRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630304 ↗
• InjuryJul 16, 2025Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A BIOPSY OF A LESION, LOCATED CA. 6CM DEEP IN THE BRAIN DIRECTLY UNDERNEATH THE LEFT VENTRICLE, AND WITH A SIZE OF CA. 2CCM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. 3-4 BIOPSY PASSES WERE INTENDED. AFTER THE FIRST BIOPSY PASS ATTEMPT ONLY YIELDED CEREBROSPINAL FLUID (CSF), THE SURGEONS RE-REGISTERED THE PATIENT ANATOMY LOCATION TO THE NAVIGATION, AND PERFORMED SUCCESSFUL BRAIN BIOPSY PASSES USING NAVIGATION, WITH THE DESIRED DIAGNOSTIC SAMPLE RETRIEVED AT THE SAME SURGERY. ACCORDING TO THE SURGEONS (TREATING CLINICIANS): - THE PURPOSE OF THIS SURGERY WAS TO RECEIVE A DIAGNOSTIC SAMPLE, NOT TO REMOVE OR TREAT THE LESION. - THE DESIRED PATHOLOGICAL/DIAGNOSTIC SAMPLE WAS RETRIEVED WITH NAVIGATION AT THE VERY SAME SURGERY. - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING BIOPSY PATH AND LOCATION, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 1H. - THERE WERE FURTHER NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. THERE WAS ALSO NO PROLONGATION OF HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517933 ↗
• InjuryMay 15, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY (ON (B)(6) 2025) FOR A TUMOR RESECTION WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB SOFTWARE CRANIAL NAVIGATION APP 4.1. DURING THE PROCEDURE, THE SURGEON OBSERVED A NAVIGATION INACCURACY, ADDRESSED IT AND REPORTEDLY RESTORED ACCURACY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): A VESSEL WAS LACERATED DURING THE RESECTION, AND IT IS UNCLEAR IF THIS WAS RELATED TO THE OBSERVED NAVIGATION INACCURACY OR DUE TO THE NATURE OF THE PROCEDURE (A ENDONASAL APPROACH HAS LIMITED WORKING ACCESS WITH SPATIAL CONSTRAINTS). THERE WAS NO PERMANENT HARM TO THE PATIENT REPORTED DUE TO THE LACERATED VESSEL, ALSO NOT DUE TO SURGERY/ANAESTHESIA TIME PROLONGED BY 30 MIN. NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS WERE REPORTED THAT WOULD HAVE BEEN NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THIS ISSUE, NOR A PROLONGATION OF HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 22025776 ↗
• InjuryApr 17, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A BIOPSY OF A LESION IN THE BRAIN, LOCATED CA. 30-40MM DEEP IN THE BRAIN AND WITH A SIZE OF CA. 0.27CCM (CA. 8MM DIAMETER), HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. ONE BIOPSY PASS WITH 8 SAMPLES WAS INTENDED. THE SURGEON DID NOT RETRIEVE THE DESIRED DIAGNOSTIC SAMPLE AT THIS SURGERY WITH 2 BIOPSY ATTEMPTS IN THE SAME PLANNED PATH, AND DETERMINED FROM A POST-OP MRI SCAN THAT THE SAMPLES TAKEN HAD MISSED THE LESION, AT THE FIRST ATTEMPT BY CA. 1CM TOO SHORT, AND AT THE SECOND ATTEMPT BY CA. 5MM MEDIAL, FROM THE DESIRED ANATOMY TARGET. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE PURPOSE OF THIS SURGERY WAS TO RECEIVE A DIAGNOSTIC SAMPLE, NOT TO REMOVE OR TREAT THE LESION. THE DESIRED PATHOLOGICAL/DIAGNOSTIC SAMPLE WAS NOT RETRIEVED AT THIS SURGERY. A REVISION SURGERY TO RETRIEVE THE DIAGNOSTIC SAMPLE IS INTENDED TO BE SCHEDULED. THERE WAS NO REPORTED DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING LOCATION OF THE BRAIN BIOPSIES. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT REPORTED, ALSO NOT DUE TO THE SURGERY/ANESTHESIA PROLONG OF CA. 30-60MIN. THERE WERE FURTHER NO REMEDIAL A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857580 ↗
• InjuryMar 7, 2025Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR PLACEMENT OF AN EXTERNAL VENTRICULAR DRAIN (EVD) INTO THE BRAIN'S VENTRICLE, AND A RESECTION OF A TUMOR LOCATED RIGHT SUB-OCCIPITAL CA. 1CM DEEP IN THE BRAIN, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. WHEN PLACING THE EVD FIRST IN A PRONE APPROACH, THE SURGEON EXPERIENCED RESISTANCE FROM THE CORPUS CALLOSUM AND DID NOT RECEIVE THE EXPECTED CEREBROSPINAL FLUID (CSF) AT 4 ATTEMPTS. THE SURGEON DETERMINED THAT THE TARGET POINT OF THE CATHETER HAD DEVIATED FROM THE DESIRED TARGET BY CA. 3MM, DECIDED TO CONTINUE WITH THE TUMOR RESECTION FIRST, AND EXTENDED THE SAME SURGERY TO PLACE THE EVD FREEHAND WITH A SUPINE APPROACH SUCCESSFULLY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF THE INITIAL EVD PLACED WITH THE AID OF NAVIGATION IN A PRONE APPROACH WAS DETECTED BY THE SURGEON IMMEDIATELY BEFORE CONTINUING WITH THE SURGERY WHEN THE EXPECTED CSF WAS NOT RECEIVED, AND THE EVD WAS SUCCESSFULLY PLACED TO ITS DESIRED TARGET POSITION FREEHAND AT THE END OF THE SAME SURGERY WITH A NEW BURR HOLE IN A SUPINE APPROACH. - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, INCLUDING THE TUMOR RESECTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21544861 ↗
• InjuryFeb 7, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR A BROAD AREA OF SEIZURE SIGNAL PROPAGATION WITH MULTIPLE FOCI, LOCATED CA. 3-4CM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE CRANIAL NAVIGATION SOFTWARE VERSION 3.1. PLACEMENT OF TWO LASER FIBERS WAS INTENDED. AFTER PLACING THE LASER FIBERS, THE SURGEON DETECTED FROM A PRE-ABLATION MRI SCAN, THAT THE LASER FIBER PATHS AND TARGET POINTS WERE DEVIATING FROM THEIR INTENDED/PLANNED LOCATION, BY CA. 3MM AND CA. 10MM. THE SURGEON DECIDED TO MODIFY THE ABLATION STRATEGY WITHOUT RE-PLACING THE LASER FIBERS, USING THE SECOND FIBER PLACED TO PERFORM LATERAL/SUPERFICIAL ABLATIONS ONLY, AND USING THE FIRST LASER PLACEMENT FOR THE PRE-PLANNED ABLATION METHOD OF CONSERVATIVE MEDIAL ABLATION FOLLOWED BY AGGRESSIVE LATERAL ABLATION. THE SURGEON WAS SATISFIED WITH THE OUTCOME OF THE ABLATION. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF THE LASER FIBERS PLACED WAS DETECTED BY THE SURGEON WITH AN MRI BEFORE ADMINISTERING THE THERMAL LASER TREATMENT IN THE BRAIN. - THE OUTCOME OF THE ABLATION SURGERY WAS SUCCESSFUL AS INTENDED, WITHOUT RE-PLACING THE LASER FIBERS. - THERE WAS NO HARM OR NEGATIVE E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21331211 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A PLACEMENT OF RESPONSIVE NEUROSTIMULATION (RNS) ELECTRODES FOR EPILEPSY TREATMENT, TARGETING BILATERAL THE RIGHT AND LEFT HIPPOCAMPUS, CA. 94MM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SOFTWARE VERSION 3.1.5. FROM INTRA-OPERATIVE CT IMAGES, THE SURGEON DISCOVERED THAT THE LEFT ELECTRODE DEVIATED BY CA. 4-5MM FROM ITS OPTIMAL PLANNED TARGET. THE DEVIATING ELECTRODE WAS CORRECTED DURING THE SAME SURGERY WITH THE AID OF NAVIGATION. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE FINAL OUTCOME OF THIS SURGERY WERE PLACEMENTS WITH ALL IMPEDANCE MEASUREMENTS WITHIN ACCEPTABLE RANGE, WHEREAS IN GENERAL FOR RNS EPILEPSY TREATMENTS THE SUCCESS OF IT CAN ONLY BE DETERMINED AFTER SWITCHING ON THE STIMULATOR, UP TO A FEW MONTHS AFTER THE SURGERY, AND AFTER TYPICALLY CONTINUOUSLY MODIFYING THE STIMULATION OVER UP TO SEVERAL YEARS. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENTS, ALSO NOT DUE TO THE PROLONG OF THE SURGERY/ANESTHESIA OF CA. 1.5 HOURS. THERE WERE FURTHER NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. THERE WAS NO PROLONG OF HOSPITALIZATION EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112019 ↗
• InjuryJan 9, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A BIOPSY OF A LESION IN THE BRAIN, A B TYPE LYMPHOMA, LOCATED ON THE RIGHT SIDE CA. 80MM DEEP IN THE BRAIN AND WITH A SIZE OF CA. 4MM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SOFTWARE VERSION 3.1. 1 PASS AND 4 SAMPLES WITHIN THE SAME PATH WERE INTENDED. THE SURGEON DETECTED FROM RECEIVING ONLY CEREBROSPINAL FLUID (CSF) FROM THE NEEDLE, THAT THE BIOPSY HAD BEEN PERFORMED IN A DIFFERENT LOCATION AND PATH THAN PLANNED AND INTENDED. AFTER CLOSING THE ORIGINAL BURR HOLE (CRANIOTOMY), THE SURGEON RE-DID THE BIOPSY WITH NAVIGATION WITH CREATING A NEW BURR HOLE AT THE SAME SURGERY, SUCCESSFULLY WITH THE BIOPSY TAKEN AT THE CORRECT LOCATION AND THE DESIRED DIAGNOSTIC SAMPLE RETRIEVED. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE PURPOSE OF THIS SURGERY WAS TO RECEIVE A DIAGNOSTIC SAMPLE, NOT TO REMOVE OR TREAT THE LESION. THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH THE DESIRED PATHOLOGICAL/DIAGNOSTIC SAMPLE RETRIEVED AT THE VERY SAME SURGERY. THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING INITIAL BRAIN BIOPSY WITH BURR HOLE. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111368 ↗
• InjuryOct 17, 2024Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR PLACEMENT OF TWO RESPONSIVE NEUROSTIMULATION (RNS) ELECTRODES FOR EPILEPSY TREATMENT IN THE BRAIN (LEFT MESIAL TEMPORAL AND LEFT PULVINAR), AT A DEPTH OF 103 MM AND 78.4 MM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SOFTWARE VERSION 3.1. A PRE-OPERATIVE MRI SCAN WAS AVAILABLE FOR THIS PATIENT AND THE TRAJECTORIES FOR THE PLACEMENTS WERE PLANNED BEFORE THE SURGERY ON THIS MRI. FROM INTRA-OPERATIVE CT SCANS, THE SURGEON DISCOVERED THAT THE INITIAL PLACEMENT OF THE LEFT MESIAL TEMPORAL ELECTRODE AS WELL AS ITS REVISION DEVIATED INFERIORLY BY APPROX. 4-5 MM. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE (TWICE) MISPLACED ELECTRODE WAS CORRECTED DURING THE VERY SAME SURGERY (WITH AID OF NAVIGATION), AND AT THE END OF THE SURGERY BOTH ELECTRODES WERE IN THE INTENDED LOCATION AND WITH ALL IMPEDANCE MEASUREMENTS WITH APPROPRIATE VALUES (IN GENERAL FOR THIS TYPE OF EPILEPSY TREATMENTS, THE STIMULATOR WILL NOT BE UTILIZED THE FIRST TWO MONTHS POST-OP, AND IT MAY TAKE 2-3 YEARS BEFORE IT IS KNOWN IF THE CLINICAL OUTCOME OF THE OVERALL SURGERY IS FAVORABLE) - THERE WAS NO ACTUAL HARM/NEGATIVE CLINICAL EFFECT TO THE PATIENT DUE TO THE MISPLA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20468956 ↗
• InjurySep 5, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR PLACEMENT OF 2 RESPONSIVE NEUROSTIMULATION (RNS) ELECTRODES FOR EPILEPSY TREATMENT, TARGETING BILATERAL THE RIGHT AND LEFT HIPPOCAMPUS, CA. 96MM AND 95MM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SOFTWARE VERSION 3.1. A PRE-OPERATIVE MRI SCAN WAS AVAILABLE FOR THIS PATIENT, AND THE TRAJECTORIES FOR THE PLACEMENTS WERE PLANNED BEFORE THE SURGERY ON THIS MRI. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A PRONE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. - ACQUIRED AN INTRA-OPERATIVE CT SCAN, WITH AN ADDITIONAL REFERENCE FRAME ATTACHED TO THE HEAD HOLDER, OF THE PATIENT'S REGION OF INTEREST WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, AND FUSED THE PRE-OPERATIVE MRI SCAN WITH THE PLANNED TRAJECTORIES TO IT. - VERIFIED THE REGISTRATION TO NAVIGATION AND THE FUSION, AND ACCEPTED THE ACCURACY TO PROCEED. - USED THE NAVIGATED POINTER WITH INSTRUMENT POSITION DISPLAY ON THE CO-REGISTERED SCANS, TO DETERMINE THE ENTRY POINTS OF THE PLANNED TRAJECTORIES, AND MARKED THESE WITH A PEN ON THE PATIENT'S HEAD S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146017 ↗
• InjuryAug 22, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A BIOPSY AND A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR A METASTASIS TO THE BRAIN, LOCATED ON THE RIGHT SIDE, CA. 66.8MM DEEP, WITH A SIZE OF CA. 16.1CM3, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION 3.1.5. PLACEMENT OF TWO LASER FIBERS WAS INTENDED, WITH TWO BIOPSIES OF THE TUMOR BEFOREHAND WITH THE SAME PATH AND TARGET. A TRAJECTORY WAS PLANNED BEFORE THE SURGERY ON A PRE-OPERATIVE MRI SCAN. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. - ACQUIRED AN INTRA-OPERATIVE CT SCAN OF THE PATIENT'S REGION OF INTEREST WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION AND FUSED THE PRE-OPERATIVE MRI SCAN WITH THE PLANNED TRAJECTORY TO IT. - VERIFIED THE ACCURACY OF THE REGISTRATION TO NAVIGATION ON ANATOMICAL LANDMARKS WITH THE NAVIGATED SOFTOUCH, AND THE FUSION, AND ACCEPTED THE ACCURACY TO PROCEED. - DETERMINED THE TRAJECTORY'S ENTRY POINT IN THE SKULL WITH THE AID OF NAVIGATION AND MARKED IT WITH A PEN ON THE PATIENT'S SKIN. - DRAPED THE PATIENT AND EXCHANGED THE NAVIGATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20040818 ↗
• InjuryAug 22, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A BIOPSY AND A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR A METASTASIS TO THE BRAIN, LOCATED LEFT FRONTAL CA. 54MM DEEP IN THE BRAIN WITH A SIZE OF CA. 0.56CCM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION VERSION 3.1. PLACEMENT OF ONE LASER FIBER WAS INTENDED, WITH A BIOPSY BEFOREHAND WITH THE SAME PATH AND TARGET. A TRAJECTORY WAS PLANNED BEFORE THE SURGERY ON A PRE-OPERATIVE MRI SCAN. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. - ACQUIRED AN INTRA-OPERATIVE CT SCAN OF THE PATIENT'S REGION OF INTEREST WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, AND FUSED THE PRE-OPERATIVE MRI SCAN WITH THE PLANNED TRAJECTORY TO IT. - VERIFIED THE ACCURACY OF THE REGISTRATION TO NAVIGATION ON ANATOMICAL LANDMARKS WITH THE NAVIGATED SOFTOUCH, AND THE FUSION, AND ACCEPTED THE ACCURACY TO PROCEED. - DETERMINED THE TRAJECTORY'S ENTRY POINT IN THE SKULL WITH THE AID OF NAVIGATION AND MARKED IT WITH A PEN ON THE PATIENT'S SKIN. - DRAPED THE PATIENT AND EXCHANGED THE NAVIGATION REFER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039430 ↗
• InjuryJul 22, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR AN ABLATION OF A TUMOR, LOCATED IN THE LEFT SIDE OF THE BRAIN CA. 60MM DEEP IN THE BRAIN AND WITH A SIZE OF CA. 2.93 CM3, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SOFTWARE VERSION 3.1.5. PLACEMENT OF ONE LASER FIBER WAS INTENDED, WITH A BIOPSY OF THE TUMOR BEFOREHAND WITH THE SAME PATH. A PRE-OPERATIVE MRI SCAN WAS ACQUIRED ON 19 DAYS BEFORE THE SURGERY. A TRAJECTORY WAS PLANNED ON THE MRI FOR THE PLACEMENT AT THE SURGERY. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. ACQUIRED AN INTRA-OPERATIVE CT SCAN OF THE PATIENT'S REGION OF INTEREST (HEAD) WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, AND FUSED THE PRE-OPERATIVE MRI SCAN WITH THE PLANNED TRAJECTORY TO IT. VERIFIED THE REGISTRATION TO NAVIGATION AND THE FUSION, AND ACCEPTED THE ACCURACY TO PROCEED. DRAPED THE PATIENT AND EXCHANGED THE NAVIGATION REFERENCE ARRAY TO A STERILE ONE. CREATED A BURR HOLE (CRANIOTOMY) OF CA. 4.5MM, BY DRILLING THROUGH A GUIDE TUBE PLACED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19790194 ↗
• InjuryJul 11, 2024Use of Device Problem; Use of Device Problem

  A PLANNED CRANIAL SURGERY FOR A BIOPSY OF A LESION, LOCATED CA. 2CM DEEP IN THE OCCIPITAL LOBE OF THE BRAIN, WITH A SIZE OF CA. 9.7CCM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SOFTWARE VERSION 3.1. 3 BIOPSY PASSES WITH 3-4 SAMPLES WERE INTENDED. A TRAJECTORY WAS PLANNED PRE-OPERATIVELY AT THE SURGERY DAY ON A PRE-OPERATIVE MRI SCAN ACQUIRED FOR THIS PATIENT 2 DAYS BEFORE THE SURGERY. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT'S HEAD IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER WITH THE HEAD TURNED LEFT AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. - PERFORMED THE PATIENT REGISTRATION TO THE PRE-OP MRI BY ACQUIRING SURFACE MATCHING REGISTRATION POINTS WITH THE SOFTOUCH REGISTRATION POINTER ON THE PATIENT HEAD'S SKIN, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - VERIFIED THE REGISTRATION RESULTS TO NAVIGATION WITH ANATOMICAL LANDMARKS, AND ACCEPTED THE ACCURACY ACHIEVED, JUDGING IT AS GOOD, TO PROCEED. - DETERMINED THE INTENDED INCISION LOCATION WITH NAVIGATION AT THE ENTRY POINT OF THE PLANNED TRAJECTORY, AND MARKED IT WITH A PEN ON THE SKIN. - DRAPED THE PATIENT, INCLUDING EXCHANGI

  Patient problems: Intracranial Hemorrhage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19718793 ↗
• InjuryMay 7, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR A RIGHT MESIAL TEMPORAL LOBE EPILEPSY, TARGETING THE AMYGDALA CA. 57MM DEEP, AND THE HIPPOCAMPUS CA. 90MM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION VERSION 3.1. PLACEMENT OF TWO LASER FIBERS WAS INTENDED, TRAJECTORIES WERE PLANNED ON AN EXISTING PRE-OPERATIVE MRI SCAN BEFORE THE SURGERY. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, WITH THE HEAD TURNED RIGHT SIDE UP, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. ACQUIRED AN INTRA-OPERATIVE CT SCAN OF THE PATIENT'S REGION OF INTEREST WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, AND FUSED THE PRE-OPERATIVE MRI SCAN WITH THE PLANNED TRAJECTORIES TO IT. VERIFIED THE REGISTRATION TO NAVIGATION ON ANATOMICAL LANDMARKS WITH THE NAVIGATED SOFTOUCH, AND THE FUSION, AND ACCEPTED THE ACCURACY TO PROCEED. DRAPED THE PATIENT AND EXCHANGED THE NAVIGATION REFERENCE ARRAY TO A STERILE ONE. STARTING WITH THE TRAJECTORY TARGETING THE HIPPOCAMPUS, CREATED A BURR HOLE (CRANIOTOMY) OF CA. 3.2MM IN THE SKULL BONE, B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257267 ↗
• InjuryMar 26, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR THE RESECTION OF RADIATION NECROSIS, LOCATED CA. 26MM DEEP IN THE SUBOCCIPITAL REGION OF THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SOFTWARE VERSION 3.1. PREOPERATIVE MR T1 AND T2 SCANS THAT WERE ACQUIRED CA. 3 WEEKS BEFORE THE SURGERY WERE USED WITH THE NAVIGATION SOFTWARE. DURING THE PROCEDURE, THE SURGEON: - POSITIONED THE PATIENT IN PRONE ORIENTATION AND ATTACHED THE 4-SPHERE STANDARD PATIENT REFERENCE ARRAY FOR NAVIGATION TO A NON-BRAINLAB HEAD HOLDER. - PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OPERATIVE MR SCANS USING THE BRAINLAB SOFTOUCH ACQUIRING POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - VERIFIED THE REGISTRATION ACCURACY AND DECIDED TO PERFORM ANOTHER REGISTRATION. - PERFORMED THE SECOND REGISTRATION -WITH MORE POINTS ACQUIRED-, VERIFIED THE REGISTRATION ACCURACY AND ACCEPTED IT TO PROCEED. - USING THE BRAINLAB POINTER, PLANNED THE INCISION AND MARKED THE ENTRY POINT ON THE SKIN BEFORE DRAPING. - VERIFIED THE NAVIGATION ACCURACY AFTER DRAPING AND SWITCHING OUT THE NON-STERILE 4-SPHERE ARRAY FOR THE STERILE ONE. - MADE THE SKIN INCISION AND, USI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978796 ↗
• InjuryFeb 9, 2024Use of Device Problem; Use of Device Problem

  WHAT IS THE ISSUE? A CRANIAL SURGERY FOR A BRAIN BIOPSY OF A 13CM3 LESION, LOCATED CA. 50 MM DEEP IN THE RIGHT FRONTAL LOBE, WAS PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SOFTWARE VERSION 3.1 WITH VARIOGUIDE. A PRE-OPERATIVE MR T1 SCAN, THAT WAS USED TO REFERENCE THE NAVIGATION DISPLAY TO, WAS ACQUIRED 1 DAY BEFORE SURGERY. DURING THE PROCEDURE, THE SURGEON: - WITH THE PATIENT IN SUPINE POSITION ATTACHED THE NAVIGATION REFERENCE ARRAY TO THE BRAINLAB VARIO REFERENCE ARM THAT WAS ATTACHED TO A NON-BRAINLAB HEAD HOLDER. - PERFORMED THE INITIAL PATIENT REGISTRATION TO THE PRE-OPERATIVE MR T1 SCAN VIA SURFACE MATCHING USING THE BRAINLAB SOFTOUCH POINTER TO ACQUIRE REGISTRATION POINTS ON THE BONY SURFACE OF THE PATIENT'S HEAD AND MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - VERIFIED THE REGISTRATION AND ACCEPTED THE ACCURACY TO PROCEED. - REMOVED THE NON-STERILE REFERENCE ARRAY AND DRAPED THE PATIENT. - BEFORE INCISION, RE-ATTACHED A STERILE REFERENCE ARRAY, ATTACHED THE BRAINLAB VARIOGUIDE TO THE HEAD HOLDER AND VERIFIED ACCURACY. - AFTER INCISION, USED THE POINTER TO CONFIRM THE ENTRY POINT ON BONE AND THEN CREATED A BURR HOLE WITH A NON-NAVIGA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18674677 ↗
• InjuryDec 20, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A BIOPSY, TO ONLY RECEIVE A DIAGNOSTIC SAMPLE OF A LESION OF 44.1CM3 IN VOLUME, LOCATED LEFT FRONTAL AT A DEPTH OF APPROX. 60 MM IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAV. SW CRANIAL 3.1.5 WITH VARIOGUIDE (ON (B)(6), 2023). ONE BIOPSY PASS WITH 12 SAMPLES AT 3 DEPTHS WAS INTENDED. PRE-OPERATIVELY A CT AND TWO MRI SCANS WERE ACQUIRED TEN DAYS BEFORE THE SURGERY (ONE OF WHICH CONTAINED MOTION ARTIFACT BUT WAS STILL USED DUE TO THE LARGE SIZE OF THE TARGET), AND A TRAJECTORY WAS PLANNED. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, WITH THE HEAD TURNED SLIGHTLY TO THE PATIENT'S RIGHT, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER - PERFORMED THE PATIENT REGISTRATION ON THE BEFOREHAND FUSED PRE-OPERATIVE CT AND MRIS BY ACQUIRING SURFACE MATCHING REGISTRATION POINTS WITH THE SOFTOUCH AND Z-TOUCH REGISTRATION POINTER ON THE PATIENT HEAD'S SKIN, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED THE REGISTRATION ACCURACY, JUDGING IT AS GOOD/VERY GOOD, AND ACCEPTED IT TO PROCEED. - PLANNED THE SKIN INCISION ENTRY POINT WITH AID

  Patient problems: Pneumocephalus

  MAUDE report 18362294 ↗
• InjuryNov 16, 2023Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A BIOPSY OF ENHANCING SYMMETRICAL LESIONS, LOCATED CA. 3-4CM DEEP IN THE BRAIN LATERAL TO THE VENTRICLES, WITH A SIZE OF CA. 1.5X4CM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SOFTWARE VERSION 3.1. ONE BIOPSY PASS WITH 8 SAMPLES WAS INTENDED. A TRAJECTORY WAS PLANNED PRE-OPERATIVELY AT THE SURGERY ON PRE-OPERATIVE MRI SCANS ACQUIRED FOR THIS PATIENT AROUND A WEEK BEFORE THE SURGERY. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT'S HEAD IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. PERFORMED THE PATIENT REGISTRATION ON THE BEFOREHAND FUSED PRE-OP MRIS BY ACQUIRING SURFACE MATCHING REGISTRATION POINTS WITH THE SOFTOUCH REGISTRATION POINTER ON THE PATIENT HEAD'S SKIN, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE REGISTRATION RESULTS TO NAVIGATION, AND ACCEPTED THE ACCURACY ACHIEVED, JUDGING IT AS VERY GOOD, TO PROCEED. DRAPED THE PATIENT INCLUDING EXCHANGING THE UNSTERILE NAVIGATION REFERENCE ARRAY TO A STERILE ONE. CHECKED THE PLANNED TRAJECTORY ON THE PATIENT'S HEAD WITH NAVIGATION, AND MARKED THE INTENDED INCISI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149167 ↗
• InjuryNov 15, 2023Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A BIOPSY OF A LESION, LOCATED CA. 35MM DEEP IN THE RIGHT SIDE OF THE BRAIN CLOSE TO THE SKULL BASE, WITH A SIZE OF CA. 4.85CCM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SOFTWARE VERSION 3.1. THREE BIOPSY PASSES WERE INTENDED. A TRAJECTORY WAS PLANNED BEFORE THE SURGERY ON PRE-OPERATIVE MRI SCANS ACQUIRED FOR THIS PATIENT CA. A WEEK BEFORE THE SURGERY. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT'S HEAD IN A LATERAL ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. PERFORMED THE PATIENT REGISTRATION ON THE PRE-OP MRI BY ACQUIRING SURFACE MATCHING REGISTRATION POINTS WITH THE Z-TOUCH LASER AND SOFTOUCH REGISTRATION POINTERS ON THE PATIENT HEAD'S SKIN, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE REGISTRATION RESULTS TO NAVIGATION CONTINUOUSLY, AND AFTER ADDING MORE REGISTRATION POINTS, ACCEPTED THE ACCURACY ACHIEVED AS SUFFICIENT TO PROCEED. CHECKED THE PLANNED TRAJECTORY WITH THE SOFTOUCH, ADJUSTED ITS PLANNED ENTRY POINT TO AN UPDATED PREFERRED POSITION, AND MARKED THE INTENDED INCISION LOCATION WITH A PEN. DRAPED THE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140973 ↗
• InjuryJul 25, 2023Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A BIOPSY OF A LESION, LOCATED RIGHT TEMPORAL CA. 41MM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SOFTWARE VERSION 3.1. ONE BIOPSY PASS WAS INTENDED. A TRAJECTORY WAS PLANNED BEFORE THE SURGERY ON A PRE-OPERATIVE MRI SCAN AVAILABLE FOR THIS PATIENT. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION WITH THE HEAD TURNED SLIGHTLY LEFT IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER. ACQUIRED AN INTRA-OPERATIVE CT SCAN OF THE PATIENT'S REGION OF INTEREST WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION. VERIFIED THE REGISTRATION TO NAVIGATION, AND ACCEPTED THE ACCURACY TO PROCEED. FUSED PRE-EXISTING MRI SCANS, INCLUDING THE PLANNED TRAJECTORY, TO THE INTRA-OP CT, AND VERIFIED THE FUSIONS ACCURACY TO PROCEED. VERIFIED THE FUSIONS AND THE REGISTRATION TO NAVIGATION, ACCEPTED THE ACCURACY TO PROCEED, AND DRAPED THE PATIENT. CREATED A BURR HOLE (CRANIOTOMY), BY DRILLING THROUGH A GUIDE TUBE PLACED INSIDE THE NAVIGATED VARIOGUIDE ALIGNED TO THE PLANNED TRAJECTORY. TOOK A BIOPSY SAMPLE FOLLOWING THE PLANNED TRAJECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389770 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092467, K192703. One submission often covers many models, so check the product and lot details in each record.

• Z-0598-2016 · Apr 22, 2013 · Terminated
  Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative imag