neuro|mate® Gen III stereotactic system neuro|mate v1.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 03662724000345), received between Oct 12, 2020 and Sep 28, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (5 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Insufficient Device Problem Information

  During a follow-up field service engineer visit after a SEEG procedure, the surgeon reported that a post-operative MRI had identified a blood clot. Patient was transferred from recovery room back to operating theatre. One electrode was removed to allow the blood clot to be removed. The surgeon advised that the finding had been treated successfully and that there was no current concern regarding the patient's condition.The surgeon stated that he did not believe the finding was related to robot accuracy. During the procedure, robot accuracy had been verified using the staple method and no concerns were identified.The surgeon requested a discussion regarding procedural factors that may influence electrode delivery.Reporting on the basis of presence of a blood clot viewed on the scan following the procedure and the return of the patient to surgery to remove an implanted electrode allowing removal of the clot. No evidence from the clinician that this was related to the use of the robot.

  Patient problems: Insufficient Information

  MAUDE report 50915885 ↗
• MalfunctionSep 25, 2026Positioning Problem

  During the surgery the surgeon reported an inaccuracy 3mm. The trajectory was revised to acceptable accuracy. The patient was successfully treated following a delay to the surgery.The device specification for accuracy is 2mm.This is being reported on the basis of the potential for direct harm if this were to happen on another occasion.

  Patient problems: Insufficient Information

  MAUDE report 50895694 ↗
• MalfunctionSep 25, 2026Positioning Problem

  After the surgery the surgeon reported an inaccuracy >2mm from the target of one electrode. The laser staple verification on the same side was offset by around 1mm. A 0.39mm frame-fit error was also reported. The patient was successfully treated.The device specification for accuracy is 2mm.This is being reported on the basis of the potential for direct harm if this were to happen on another occasion.

  Patient problems: Insufficient Information

  MAUDE report 50895667 ↗
• MalfunctionDec 22, 2025Positioning Problem; Positioning Problem

  DURING THE INITIAL STAGES OF THE SURGERY BEFORE THE SURGEON HAD PUT KNIFE TO SKIN THE ROBOT GOT STUCK IN POSITION WHEN THE SURGEON TRIED TO DO THE NEUROLOCATE REGISTRATION TO CONFIRM THE POSITION OF THE PATIENT WITHIN THE ROBOT SPACE. THE SURGEON CHOSE TO CONTINUE THE SURGERY BY ANOTHER MEANS AND THE PATIENT WAS SUCCESSFULLY TREATED. IN ANOTHER OCCASION THE SURGEON MAY HAVE HAD TO CANCEL THE PROCEDURE GIVING THE PATIENT ANAESTHETIC WITH NO THERAPEUTIC BENEFIT, THIS IS BEING REPORTED ON THIS BASIS OF THIS POTENTIAL INDIRECT HARM IF IT WERE TO OCCUR ON ANOTHER OCCASION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863787 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE IMPLANTATION OF THE NEUROPACE RNS DEVICE (MFR NEUROPACE) USING THE NEUROMATE ROBOT, PERSONNEL AT NEUROPACE WERE MADE AWARE ON A ISSUE WITH A PATIENT. INFORMATION WAS LATER PROVIDED TO RENISHAW BY PERSONNEL AT NEUROPACE. THE CLINICIAN WAS CONTACTED DIRECTLY WHO CONFIRMED THAT A PATIENT HAD AN ADVERSE EVENT BUT STATED THAT THEY DID NOT ATTRIBUTE IT TO EITHER THE RNS DEVICE OR THE RENISHAW ROBOT. NO FURTHER INFORMATION WAS OBTAINED FROM THE CLINICIAN.

  Patient problems: Insufficient Information

  MAUDE report 23788305 ↗
• MalfunctionDec 4, 2025Use of Device Problem; Use of Device Problem

  3 SURGERIES WERE PLANNED FOR 24TH NOVEMBER: DBS, SEEG AND LITT. FOLLOWING A COLLISION BETWEEN THE ROBOT ARM AND ANOTHER PIECE OF SURGICAL EQUIPMENT IN THE FIRST SURGERY THE CLINICIAN CONTINUED WITH THE SURGERIES PLANNED FOR THE REST OF THE DAY. SUBSEQUENT SURGERIES SHOWED INACCURACIES IN TRAJECTORY, LEADING TO THE SECOND SURGERY HAVING A 3-4MM INACCURACY AND THE 3RD SURGERY BEING CANCELLED. DBS - VERY GOOD ACCURACY ON VERIFICATION TRAJECTORY (ON THE LEKSELL FRAME) AND DURING THE SURGERY. AT THE END OF THE SURGERY THE ROBOT APPARENTLY COLLIDED WITH A SURGICAL SEPARATOR AND GOT BLOCKED (LOST CONNECTION). THE CLINICIAN MANAGED TO REGAIN THE CONTROL OF THE ARM AND INSISTS THE COLLISION/CONTACT WAS VERY LIGHT. SEEG (9 ELECTRODES) - VERIFICATION TRAJECTORY SHOWED A 3-4MM ERROR AND THE SURGEON DECIDED TO PROCEED WITH THE SURGERY. THE SAME ERROR WAS CONFIRMED DURING SURGERY (ERROR ON ALL TRAJECTORIES IN THE SAME DIRECTION). CLINICIAN PUTS SEEG FIXATION SCREWS FIRST AND THEN IF ACCURACY IS ACCEPTABLE IMPLANTS THE ELECTRODES. LITT - SURGERY ABORTED AS 3-4MM ERROR IN THIS TYPE OF PROCEDURE WAS NOT ACCEPTABLE TO THE SURGEON. THE PATIENT WAS NOT UNDER GA WHEN THE SURGERY WAS CANCELLED. THIS IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717888 ↗
• MalfunctionNov 20, 2025Battery Problem; Battery Problem

  NM ROBOT EMITS CONTINUOUS BEEPING SOUND. CUSTOMER UNABLE TO USE THE ROBOT. CUSTOMER SUCCESSFULLY PERFORMED THE DIAGNOSTICS AND VERIFICATION TRAJECTORIES. WHEN THEY WERE ABOUT TO DELIVER THE FIRST DBS TRAJECTORY STARTING FROM THE PARKING POSITION, THE ROBOT STARTED TO CONTINUOUSLY BEEP. THE SURGERY COULD NOT CONTINUE TO THE ROBOT NOT WORKING. THE SURGERY WAS CANCELLED. INCIDENT REPORTED DUE TO INDIRECT HARM. PATIENT WAS PLACED UNDER GENERAL ANAESTHETIC BUT RECEIVED NO TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602447 ↗
• InjuryNov 20, 2025Malposition of Device; Malposition of Device

  DURING A DEEP BRAIN STIMULATION ELECTRODE INSERTION USING THE NEUROMATE ROBOT THE 2ND ELECTRODE OUT OF THREE HAD AN INACCURACY OF 5MM ANTERIOR - THIS IS OUTSIDE OF THE MANUFACTURERS SPECIFICATION THE OTHER TWO TRAJECTORIES WERE WITHIN SPECIFICATION. THE INCORRECT ELECTRODE HAD TO BE REPLACED IN THE CORRECT PLACE RESULTING IN A LONGER PERIOD IN SURGERY. THERE WAS NO IMPACT TO THE PATIENT REPORTED. IF THE INACCURACY WERE TO HAPPEN AGAIN, UNDER DIFFERENT CIRCUMSTANCES, THE POSSIBLE IMPACT IS THAT IT COULD CAUSE DAMAGE IF UNINTENDED STRUCTURE ARE PASSED THROUGH, AND AN INCORRECT PART OF THE BRAIN MAY BE OPERATED ON. ALTHOUGH IT IS UNLIKELY THAT THIS ISSUE COULD RESULT IN DEATH OR SERIOUS INJURY, THERE IS A POTENTIAL FOR SUCH AN OUTCOME IN THE WORST-CASE SCENARIO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602432 ↗
• MalfunctionAug 5, 2025Positioning Failure; Positioning Failure

  A ROBOT INACCURACY OF ~3MM WAS DETECTED DURING REGISTRATION OF THE PATIENT TO ROBOT SPACE AS DETECTED ON A REGISTRATION STAPLE. THE SURGEON THEREFORE AMENDED THE TRAJECTORY BY THE OFFSET TO ENSURE THAT THE DEVICE WAS PLACED WHERE INTENDED. THERE WAS NO ISSUE SEEN WITH THE FINAL PLACEMENT OF THE DEVICE. IF THE INACCURACY WERE TO HAPPEN AGAIN, UNDER DIFFERENT CIRCUMSTANCES AND THE CLINICIAN DID NOT CORRECT FOR THE OFFSET SEEN, THE POSSIBLE IMPACT IS THAT IT COULD CAUSE DAMAGE IF UNINTENDED STRUCTURE ARE PASSED THROUGH, AND AN INCORRECT PART OF THE BRAIN MAY BE OPERATED ON. ALTHOUGH IT IT IS UNLIKELY THAT THIS ISSUE COULD RESULT IN DEATH OR SERIOUS INJURY, THERE IS A POTENTIAL FOR SUCH AN OUTCOME IN THE WORST-CASE SCENARIO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714013 ↗
• MalfunctionJul 3, 2025Application Program Problem; Application Program Problem

  DURING A SURGERY WHERE A PATIENT WAS UNDER GENERAL ANATHESTIC, THE NEUROINSPIRE SOFTWARE CRASHED ON MULTIPLE OCCASIONS, WHEN THE SURGEON TRIED TO IMPORT AN MRI IMAGE. THE SAME ISSUE OCCURS WHEN TRYING TO IMPORT A INTEROPERATIVE CT SERIES DONE WITH THE O-ARM. AS A RESULT OF THIS ISSUE, THE SURGERY WAS CANCELLED. THE IMPACT TO THE PATIENT HAS NOT BEEN CONFIRMED, BUT A FURTHER SURGERY FOR THIS PATIENT IS SCHEDULED FOR (B)(6) 2025. NO HARM TO PATIENT BUT MEDICAL INTERVENTION REQUIRED TO CLOSE PATIENT WITH NO CLINICAL BENEFIT. PATIENT RECOVERED FROM GA. THE SURGEON NEEDED TO SURGICALLY CLOSE THE PATIENT UP WITHOUT BEING ABLE TO COMPETE THE PLANNED SURGERY. THIS IS BEING REPORTED ON THE BASIS OF THE SURGICAL INTERVENTION TO CLOSE THE PATIENT AT AN UNPLANNED STAGE OF THE SURGERY DUE TO A MALFUNCTION OF THE DEVICE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395350 ↗
• MalfunctionJul 3, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down

  DURING SURGERY, A PATIENT WAS UNDER ANAESTHESIA, ADDITIONAL IMAGES WERE BEING IMPORTED FOLLOWING A SCAN WITH AN O ARM TO COLLECT THE 3D NEUROLOCATE IMAGE SERIES TO ALLOW REGISTRATION OF THE PATIENT TO THE ROBOT COORDINATES. THE NEUROINSPIRE SOFTWARE WITHIN THE ROBOT SYSTEM BROUGHT UP AN ERROR MESSAGE. FOLLOWING ATTEMPTS TO RESTART THE PC AND TRANSFER THE IMAGES FROM PACS AND USB STICK THE IMAGES WOULD STILL NOT UPLOAD SO SURGERY WAS CANCELLED. NO HARM TO PATIENT BUT MEDICAL INTERVENTION REQUIRED TO CLOSE PATIENT WITH NO CLINICAL BENEFIT. PATIENT RECOVERED FROM GA. 3D NEUROLOCATE NOT AVAILABLE FOR SALE IN THE USA, BUT THE IMAGE UPLOAD ISSUE IS UNLIKELY TO BE DUE TO THE USE OF 3D NEUROLOCATE. THE SURGEON NEEDED TO SURGICALLY CLOSE THE PATIENT UP WITHOUT BEING ABLE TO COMPETE THE PLANNED SURGERY. THIS IS BEING REPORTED ON THE BASIS OF THE SURGICAL INTERVENTION TO CLOSE THE PATIENT AT AN UNPLANNED STAGE OF THE SURGERY DUE TO A MALFUNCTION OF THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 22395325 ↗
• MalfunctionJul 3, 2025Positioning Failure; Positioning Failure

  DURING A SURGERY, WHERE THE PATIENT WAS UNDER GENERAL ANESTHETIC AND OPEN, THERE WAS AN PROBLEM WITH THE SYSTEM WHICH BLOCKED THE FIRST TRAJECTORY BEING SENT TO THE NEUROMATE. REMEDIATION ACTION WAS TAKEN TO RESTART THE SYSTEM, BUT THE PROBLEM PERSISTED - THEREFORE THE SURGERY WAS CANCELLED. NO HARM TO PATIENT BUT MEDICAL INTERVENTION REQUIRED TO CLOSE PATIENT WITH NO CLINICAL BENEFIT. PATIENT RECOVERED FROM GA. THE SURGEON NEEDED TO SURGICALLY CLOSE THE PATIENT UP WITHOUT BEING ABLE TO COMPETE THE PLANNED SURGERY. THIS IS BEING REPORTED ON THE BASIS OF THE SURGICAL INTERVENTION TO CLOSE THE PATIENT AT AN UNPLANNED STAGE OF THE SURGERY DUE TO A MALFUNCTION OF THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 22395304 ↗
• MalfunctionJul 3, 2025Operating System Becomes Nonfunctional; Application Program Freezes or Fails to Launch; Operating System Becomes Nonfunctional; Application Program Freezes or Fails to Launch

  NEUROINSPIRE IS THE SOFTWARE IN THE NEUROMATE ROBOT SYSTEM DURING SURGERY, WHERE A PATIENT WAS UNDER GENERAL ANESTHETIC THERE WERE ISSUES WITH THE PLAN FUNCTIONALITY. 1. NEUROINSPIRE WOULD NOT SAVE PLANS WITH NEW SERIES ADDED. 2. WHEN NEUROINSPIRE WAS IN RECOVERY MODE THE ORIGINAL PLAN WOULD NOT OPEN. 3. UNABLE TO OPEN ANY HISTORIC PLANS IN NEUROINSPIRE. IT SUPPORT WAS PROVIDED ENABLING THE NEUROINSPIRE SESSION TO BE TERMINATED, BUT PLANS COULD NOT BE OPENED AT ALL. THE SURGERY WAS UNABLE TO PROCEED AND THEREFORE THE SURGERY WAS CANCELLED. THE SURGEON NEEDED TO SURGICALLY CLOSE THE PATIENT UP WITHOUT BEING ABLE TO COMPETE THE PLANNED SURGERY. THIS IS BEING REPORTED ON THE BASIS OF THE SURGICAL INTERVENTION TO CLOSE THE PATIENT AT AN UNPLANNED STAGE OF THE SURGERY DUE TO A MALFUNCTION OF THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 22395292 ↗
• MalfunctionJul 3, 2025Intermittent Communication Failure; Intermittent Communication Failure

  DURING A SEEG SURGERY, THE ROBOT LOST INITIALISATION. THE USER HAD TRIED USING THE DIAGNOSTIC CHECKS TO RESOLVE THE ISSUE BEFORE PHONING FOR SUPPORT. DURING THE DIAGNOSTIC CHECKS, THE SYSTEMS INTERMITTENTLY FAILED THE INITIALISATION CHECK. THE USER HAD ALSO INSTALLED THE SPARE COMMUNICATIONS CABLE BUT THIS DID NOT RESOLVE THE ISSUE. THE PATIENT WAS UNDER GENERAL ANESTHETIC WHEN THIS OCCURRED, SURGERY WAS SUBSEQUENTLY CANCELLED WITHOUT THE TREATMENT BEING COMPLETED. THE SURGERY WAS ABANDONED PRIOR TO KNIFE TO SKIN, AND THE PATIENT SUFFERED NO ILL-EFFECT FROM BEING UNDER ANESTHETIC. NO HARM TO PATIENT AND NO MEDICAL INTERVENTION REQUIRED. PATIENT JUST RECOVERED FROM GA. THIS IS BEING REPORTED BECAUSE IF THIS HAD OCCURRED ON ANOTHER OCCASION IT MAY HAVE BEEN AT ANOTHER PART OF THE PROCEDURE WHICH WOULD HAVE REQUIRED SURGICAL INTERVENTION TO CLOSE THE PATIENT AT AN UNPLANNED STAGE BEFORE THE SURGERY HAD BEEN COMPLETED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395262 ↗
• MalfunctionJul 3, 2025Operating System Version or Upgrade Problem; Application Program Freezes or Fails to Launch; Operating System Version or Upgrade Problem; Application Program Freezes or Fails to Launch

  THE NEUROINSPIRE SOFTWARE WAS NOT AVAILABLE TO COMPLETE A SURGERY WITH THE PATIENT UNDER A GENERAL ANESTHETIC AT THE TIME. THE UNAVAILABILITY OF THE SOFTWARE WAS DUE TO TWO SEPARATE ISSUES: 1. THE REGISTRATION OF THE PATIENT TO THE ROBOT USING THE ULTRASOUND MODULE WITHIN THE SOFTWARE FAILED ON 3 OCCASIONS; AND 2. MICROSOFT WINDOWS FORCED AN UPDATE DURING SURGERY, WHICH MEANT THE CLINICIAN WAS UNABLE TO ACCESS THE SOFTWARE. THIS RESULTED IN A DELAY; THEREFORE, THE CLINICIAN TOOK THE DECISION TO CANCEL THE SURGERY. THE SURGEON NEEDED TO SURGICALLY CLOSE THE PATIENT UP WITHOUT BEING ABLE TO COMPETE THE PLANNED SURGERY. THIS IS BEING REPORTED ON THE BASIS OF THE SURGICAL INTERVENTION TO CLOSE THE PATIENT AT AN UNPLANNED STAGE OF THE SURGERY DUE TO A MALFUNCTION OF THE DEVICE. THE ULTRASOUND MODULE IS NOT AVAILABLE IN THE USA BUT THE WINDOWS ISSUE COULD OCCUR IN THE VERSION AVAILABLE IN THE USA, SO IS BEING REPORTED EVEN THOUGH IT WAS NOT CLEAR WHICH ISSUE WAS THE CAUSE OF THE CANCELLATION OF SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 22395113 ↗
• MalfunctionJun 25, 2025Malposition of Device; Malposition of Device

  DURING A BIOPSY SURGERY THE CLINICIAN REPORTED A 3MM INACCURACY FROM INTENDED TARGET POSITION OF THE BIOPSY SAMPLE. NO FURTHER INFORMATION IS AVAILABLE ON THE IMPACT ON THE PATIENT. IF THE INACCURACY WERE TO HAPPEN AGAIN, UNDER DIFFERENT CIRCUMSTANCES, THE POSSIBLE IMPACT IS THAT IT COULD CAUSE DAMAGE IF UNINTENDED STRUCTURE ARE PASSED THROUGH, AND AN INCORRECT PART OF THE BRAIN MAY BE OPERATED ON. ALTHOUGH IT IS UNLIKELY THAT THIS ISSUE COULD RESULT IN DEATH OR SERIOUS INJURY, THERE IS A POTENTIAL FOR SUCH AN OUTCOME IN THE WORST-CASE SCENARIO.

  Patient problems: Insufficient Information

  MAUDE report 22327380 ↗
• MalfunctionFeb 21, 2025Imprecision; Imprecision

  DURING A SEEG (STEREOELECTROENCEPHALOGRAPHY) SURGERY WHILST THE PATIENT WAS UNDER A GENERAL ANAESTHETIC, SOME INACCURACIES OF BETWEEN 1.70MM (WITHIN MANUFACTURERS SPECIFICATION) TO 2.40MM (OUTSIDE OF MANUFACTURERS SPECIFICATION) OF THE ELECTRODE PLACEMENT WAS OBSERVED. NOTE THAT NOT ALL OF THE TRAJECTORIES WERE OFF TARGET IN THIS CASE. THE INACCURACIES WERE ACCEPTED BY THE SURGEON AS ACCEPTABLE TO PROCEED TO WITH THE SURGERY, THIS IS BECAUSE THE SEEG SURGERY IS TO TARGET A REGION WITHIN THE BRAIN, THEREFORE ACCURACY IS LESS CRITICAL. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS SUCCESSFULLY TREATED. THE CAUSE OF THE INACCURACY HAS YET TO BE DETERMINED. A POSSIBLE IMPACT OF AN INACCURACY OF THIS NATURE IS THAT IT COULD CAUSE DAMAGE IF UNINTENDED STRUCTURES ARE PASSED THROUGH, AND AN INCORRECT PART OF THE BRAIN MAY BE OPERATED ON IF THIS SITUATION WAS TO REOCCUR UNDER DIFFERENT CIRCUMSTANCES. ALTHOUGH IT IS UNLIKELY THAT THIS ISSUE COULD RESULT IN DEATH OR SERIOUS INJURY, THERE IS A POTENTIAL IN THE WORST CASE SCENARIO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431179 ↗
• InjuryFeb 21, 2025Positioning Problem; Positioning Problem

  THE NEUROMATE STEREOTACTIC SYSTEM, IN CONJUNCTION WITH AN MRI GUIDED LASER ABLATION SYSTEM FROM A THIRD-PARTY MEDICAL DEVICE MANUFACTURER, WAS USED TO PERFORM A LASER INTERSTITIAL THERMAL THERAPY (LITT) SURGERY ON (B)(6) 2025. DURING THE PROCEDURE, RADIAL ERRORS WERE OBSERVED, WITH ONE TRAJECTORY DEVIATING BY 3MM AND ANOTHER BY 5MM. THE NEUROMATE STEREOTACTIC SYSTEM TRAJECTORIES HAD BEEN VERIFIED BY LASER VERIFICATION PRIOR TO THE CASE, CONFIRMING ACCURATE TARGETING ON THE STAPLE. THE STANDARD WORKFLOW INVOLVES DELIVERING THE GUIDE SCREW USING THE NEUROMATE STEREOTACTIC SYSTEM, FOLLOWED BY THE INSERTION OF THE LASER CATHETER UNDER THE GUIDE SCREW AS PART OF THE MRI GUIDED LASER ABLATION SYSTEM. SUBSEQUENT TO THE COMPLETION OF THE SURGERY ON (B)(6) 2025, THE SURGEON REPORTED THAT DURING THE PROCEDURE, WHILE THE PATIENT WAS UNDER GENERAL ANAESTHESIA AND IN THE MRI, THE PATIENT EXPERIENCED A HAEMORRHAGE, LEADING TO THE ABORTION OF THE SURGERY. THE PATIENT UNDERWENT A CRANIOTOMY TO EVACUATE THE HAEMORRHAGE. THEY ARE NOW IN THE ICU ON A VENTILATOR AND ARE EXPERIENCING PARALYSIS ON THE LEFT SIDE OF THEIR BODY DUE TO THE HAEMORRHAGE BUT CAN FOLLOW COMMANDS BRISKLY ON THE RIGHT SIDE. THEIR

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Paralysis

  MAUDE report 21431159 ↗
• MalfunctionFeb 10, 2025Malposition of Device; Malposition of Device

  DURING A SURGERY WHILST THE PATIENT WAS UNDER GENERAL ANAESTHETIC. AN INACCURACY OF 2-3MM WAS OBSERVED. THIS INACCURACY IS OUTSIDE OF THE MANUFACTURERS SPECIFICATION. THE CAUSE OF THE INACCURACY HAS YET TO BE DETERMINED. IN THIS INSTANCE THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WERE NO HEALTH IMPACTS TO THE PATIENT. A POSSIBLE IMPACT OF AN INACCRACY OF THIS NATURE IS THAT IT COULD CAUSE DAMAGE IF UNINTENDED STRUCTURE ARE PASSED THROUGH, AND AN INCORRECT PART OF THE BRAIN MAY BE OPERATED ON IF THIS SITUATION WAS TO REOCCUR UNDER DIFFERENT CIRCUMSTANCES. ALTHOUGH IT IT IS UNLIKELY THAT THIS ISSUE COULD RESULT IN DEATH OR SERIOUS INJURY, THERE IS A POTENTIAL FOR SUCH AN OUTCOME IN THE WORST-CASE SCENARIO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343785 ↗
• MalfunctionNov 21, 2024Malposition of Device; Malposition of Device

  THIS ISSUE OCCURRED IN BORDEAUX, FRANCE, BUT IS BEING DOCUMENTED AS A PRECAUTIONARY MEASURE BECAUSE IT INVOLVES A DEVICE THAT HAS BEEN CLEARED IN THE US AND MEETS THE REPORTING REQUIREMENTS ACCORDING TO CFR 803.50 (2). DURING A DBS SURGERY, AN INACCURACY IN THE PLACEMENT OF THE ELECTRODE WAS OBSERVED. THE ELECTRODE WAS DELIVERED USING THE NEUROMATE SYSTEM. THE INACCURACY OBSERVED EXCEEDED THE SPECIFICATIONS OF THE NEUROMATE SYSTEM SET BY THE MANUFACTURER. AT THIS TIME IT HAS NOT BEEN CONCLUDED IF A DEVICE MALFUCTION WAS THE CAUSE OF THE INACCURACY. THE POSSIBLE IMPACT OF THIS INACCURACY IS THAT IT COULD CAUSE DAMAGE IF UNINTENDED STRUCTURES ARE PASSED THROUGH, AND THE DBS LEADS MIGHT BE PLACED IN THE INCORRECT PART OF THE BRAIN. ALTHOUGH IT IS UNLIKELY THAT THIS ISSUE COULD RESULT IN DEATH OR SERIOUS INJURY, THERE IS A POTENTIAL FOR SUCH AN OUTCOME IN THE WORST-CASE SCENARIO.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20742647 ↗
• MalfunctionNov 21, 2024Malposition of Device; Malposition of Device

  THIS ISSUE OCCURRED IN VALENCIA, SPAIN, BUT IS BEING DOCUMENTED AS A PRECAUTIONARY MEASURE BECAUSE IT INVOLVES A DEVICE THAT HAS BEEN CLEARED IN THE US AND MEETS THE REPORTING REQUIREMENTS ACCORDING TO CFR 803.50 (2). DURING A LITT (LASER INTERSTITIAL THERMAL THERAPY) SURGERY WHERE THE PATIENT WAS UNDER ANAESTHETIC, AN INACCURACY WAS OBSERVED. THE INACCURACY OBSERVED WAS 20MM. THE SURGERY WAS CANCELLED. THE CAUSE OF THE INACCURACY HAS NOT BEEN DETERMINED YET. THE POSSIBLE IMPACT OF THIS INACCURACY IS THAT IT COULD CAUSE DAMAGE IF UNINTENDED STRUCTURES ARE PASSED THROUGH, IF IT WERE TO REOCCUR, AND THE INCORRECT PART OF THE BRAIN MAY BE OPERATED ON. ALTHOUGH IT IS UNLIKELY THAT THIS ISSUE COULD RESULT IN DEATH OR SERIOUS INJURY, THERE IS A POTENTIAL FOR SUCH AN OUTCOME IN THE WORST-CASE SCENARIO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20742646 ↗
• MalfunctionSep 14, 2021Application Program Version or Upgrade Problem; Application Program Version or Upgrade Problem

  THE PLANNING STATION OF THE NEUROMATE AT (B)(6) HOSPITAL IN (B)(6) WAS UPGRADED TO (B)(6) VIA HARD DRIVE REPLACEMENT . THE FIRST CASE TO USE THE NEW UPGRADED SYSTEM WAS DELAYED WHILE THE PATIENT WAS IN ROOM AND UNDER ANAESTHESIA BECAUSE THE NEUROMATE COULD NOT ESTABLISH A COMMUNICATION WITH NEUROINSPIRE WHEN ATTEMPTING TO OPEN THE NEUROMATE MODULE. OVER THE PHONE WITH THE FIELD SERVICE ENGINEER, THE SURGEON WAS DIRECTED TO THE APPROPRIATE CONFIGURATION FILE FOR NEUROINPIRE IN ORDER TO UPDATE THE COM PORT TO THE CORRECT PORT. THE SURGERY WAS DELAYED OF 1 HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467468 ↗
• MalfunctionOct 12, 2020Incorrect Measurement; Device Markings/Labelling Problem

  WHILE PLANNING A CASE USING THE TIP OFFSET FEATURE WITHIN THE SURGICAL PLANNING SOFTWARE WITHIN THE SYSTEM, THE SURGEON NOTICED IN THE IFU THAT THERE IS A DISCREPANCY IN A DIAGRAM IDENTIFYING THE ROBOT DATUM POINT. WHILE PLANNING A CASE USING THE TIP OFFSET FEATURE WITHIN THE SURGICAL PLANNING SOFTWARE (NEUROINSPIRE) WITHIN THE NEUROMATE SYSTEM, THE SURGEON NOTICED IN THE IFU THAT THERE IS A DISCREPANCY IN A DIAGRAM IDENTIFYING THE ROBOT DATUM POINT. IN SECTION 3.4, OF THE NEUROINSPIRE-NEUROMATE IFU H-5630-3016-A4, THE GRAPHIC IN THE LOWER RIGHT SHOWS THE DATUM POINT TO BE A SURFACE ON THE TOOL HOLDER, NOT ON THE GUIDE BUSHING. THIS GRAPHIC DIFFERS FROM THE INFORMATION GIVEN THROUGH CUSTOMER TRAINING, AND IN OTHER PARTS OF THE IFU. THE DISCREPANCY CAUSED A LACK OF CONFIDENCE IN THE MEASUREMENTS. TO RESOLVE THE CONFIDENCE ISSUE, DURING THE CASE, THE SURGEON PLANNED A TARGET ON THE SURFACE OF THE PATIENT'S SCALP, TESTED THE OFFSETS, AND DISTANCES USING A MEASUREMENT TOOL, CONFIRMING THE ROBOT DATUM TO BE ON THE BACK OF THE GUIDE BUSHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10660968 ↗