N/A 9733068 (UDI 00643169702943)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00643169702943), received between Oct 17, 2016 and Oct 27, 2025 — classified as 1 injury, 38 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT AFTER REGISTERING THE PATIENT AND SWITCHING TO NAVIGATION MODE, WHERE THE SUBSEQUENT TRAJECTORY CREATION FOR THE OPTICAL BIOPSY ENTRY TOOK PLACE, THE NAVIGATION COULD NOT DISPLAY THE BIOPSY NEEDLES (THE NAVIGATION BALLS ON THE STEALTH STATION S8 SYSTEM CAMERA WERE NOT VISIBLE). THE BALLS ON THE NEEDLE WERE FIXED AND DID NOT MOVE. THE NEEDLES WERE REPLACED WITH TWO PIECES AND THE SAME LOT NUMBER. THE SITE WAS USING DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) EXAM, STEALTH ARCHIVE EXAM, AND CORE FILES. NO KNOWN IMPACT TO PATIENT OUTCOME. THERE WAS A 30 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391543 ↗
• MalfunctionOct 27, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT AFTER REGISTERING THE PATIENT AND SWITCHING TO NAVIGATION MODE, WHERE THE SUBSEQUENT TRAJECTORY CREATION FOR THE OPTICAL BIOPSY ENTRY TOOK PLACE, THE NAVIGATION COULD NOT DISPLAY THE BIOPSY NEEDLES (THE NAVIGATION BALLS ON THE STEALTH STATION S8 SYSTEM CAMERA WERE NOT VISIBLE). THE BALLS ON THE NEEDLE WERE FIXED AND DID NOT MOVE. THE NEEDLES WERE REPLACED WITH TWO PIECES AND THE SAME LOT NUMBER. THE SITE WAS USING DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) EXAM, STEALTH ARCHIVE EXAM, AND CORE FILES. NO KNOWN IMPACT TO PATIENT OUTCOME. THERE WAS A 30 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391540 ↗
• MalfunctionSep 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE WHITE SCREW OF THE BLUE DEPTH STOP OF THE NEEDLE WAS FAULTY. THUS, THE DEPTH STOP WOULD NOT STAY IN POSITION. THE ISSUE WAS NOTICED BEFORE INSERTING THE NEEDLE INTO THE PATIENT'S BRAIN AND WAS REPLACED IMMEDIATELY. THE ISSUE WAS RESOLVED BY REPLACING THE ENTIRE PRODUCT WITH ANOTHER PRODUCT LOT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064142 ↗
• MalfunctionSep 5, 2025Contamination; Mechanical Problem; Contamination; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE SAMPLE COULD NOT BE DRAWN WITH THE BIOPSY NEEDLE. THERE WAS ALSO DIRT ON THE BLUE PART OF THE OUTER TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976973 ↗
• MalfunctionFeb 21, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE BIOPSY NEEDLE APPEARED TO BE DEFORMED WHEN IT WAS REMOVED FROM THE PACKAGING. THE CUTTING WINDOW APPEARED TO BE ALMOST CLOSED IN ON ITSELF. THERE WAS A 20 MINUTE DELAY WHILE A NEW NEEDLE WAS SOURCED. THERE WAS NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DAMAGE WAS CONSIDERED AN OUT OF BOX FAILURE AND THE INSTRUMENT HAD BEEN USED ON A PATIENT. IT WAS DISCOVERED AFTER TISSUE SAMPLES WERE ATTEMPTED TO BE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434237 ↗
• MalfunctionFeb 20, 2025Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT SURGEON WAS PERFORMING A NAVIGUS BIOPSY AND WAS UNABLE TO ASPIRATE OR IRRIGATE THE INTERNAL CHANNEL OF THE BIOPSY NEEDLE. ANOTHER NEEDLE KIT WAS OPENED AND PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21425687 ↗
• MalfunctionDec 5, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE BIOPSY NEEDLE WAS NOT TRACKING WHEN PLACED IN THE REDUCING TUBE. ANOTHER NEEDLE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT IMPACT AND A DELAY OF LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852737 ↗
• MalfunctionNov 6, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT DURING A CASE, THE SITE COULD NOT GET BIOPSY NEEDLE TO TRACK. THE SITE SWAPPED SPHERES, CLEANED, AND IT WOULDN'T SHOW UP IN TRACKING WINDOW. THE SITE USED ANOTHER NEEDLE AND THAT NAVIGATED FINE. THIS OCCURRED INTRAOPERATIVELY, AND THERE WAS NO SURGICAL DELAY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THAT THE MOST LIKELY CAUSE WAS THAT THE NEEDLE WAS BENT CAUSING THE SYSTEM NOT TO TRACK IT. IT'S SUSPECTED THAT THE NEEDLE WAS BENT WHILE THE SCRUB WAS SETTING UP THEIR TABLE. THE REASON IS BECAUSE WHEN THE SPHERES WERE VISUALLY INSPECTED, THEY APPEARED TO BE FINE. WHEN ANOTHER NEEDLE WAS DROPPED IT TRACKED FINE SO THE SYSTEM HAVING AN ISSUE WAS ELIMINATED AS A SUSPECTED CAUSE. IT WAS NOTED THAT THE GEOMETRY OF THE NEEDLE WAS NOT CONFIRMED IF IT MET STANDARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621008 ↗
• MalfunctionOct 18, 2023Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE SURGEON MADE TARGET ALIGNMENT WITH THE VERTEK BIOPSY SET AND LOCKED TRAJECTORY. THE SURGEON THEN SET MECHANICAL DEPTH STOP OF THE NEEDLE, AND HE SENT THE BIOPSY NEEDLE TO THE TARGET AREA. THE SURGEON OPENED THE SAMPLING WINDOW TO GET THE SAMPLE FROM THE DESIRED AREA. AT THIS STAGE WHEN THE SURGEON TRIED TO MAKE NEGATIVE PRESSURE WITH SYRINGE, HE FELT THAT HE COULD NOT CREATE ENOUGH PRESSURE EVEN IF HE USED MORE THAN NORMAL. THEN, THE SURGEON TOOK OUT THE INNER CANNULA AND TRIED TO WASH INSIDE OF IT TO UNDERSTAND WHETHER IT HAD A BLOCKAGE OR NOT. THE SURGEON ALSO SAW THAT WASHING WAS VERY HARD. THE SURGEON FINISHED SURGERY WITH THIS NEEDLE SUCCESSFULLY, BUT AFTER THE SURGERY HE WANTED TO SEND THIS NEEDLE FOR FURTHER INVESTIGATION. THERE WAS NO DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961843 ↗
• MalfunctionMay 30, 2023Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED INTRAOPERATIVELY IN A CRANIAL BIOPSY IN WHICH THERE WAS PATIENT IN VOLVEMENT. IT WAS REPORTED THAT THE BIOPSY NEEDLES' LOCKING MECHANISM FOR DEPTH STOP WOULD MAKE A CLICKING NOISE AND WOULD NOT LOCK. THE SURGEON STILL PROCEEDED WITH THE INSTRUMENT. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND NO DELAY IN SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019697 ↗
• MalfunctionFeb 13, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED IN A CRANIAL BIOPSY. IT WAS REPORTED THE SURGICAL PLAN HAD BEEN MADE AND TRAJECTORY GUIDE COLLAR MOUNTED. TRAJECTORY WAS LOCKED FOLLOWING INSERTION OF THE PROBE, BUT THE BIOPSY NEEDLE COULD NOT BE TRACKED BY THE NAVIGATION SYSTEM. SURGEON CONFIRMED THAT THE CORRECT PROCEDURE HAD BEEN SELECTED, REALIGNED TRAJECTORY WITH THE PROBE AND RE-LOCKED TRAJECTORY WITHOUT SUCCESS. THE NEEDLE WAS INSERTED INTO THE GUIDE TUBE AND STILL WAS NOT ABLE TO BE TRACKED. OPERATING THEATRE LIGHTS AND OVERHEAD LIGHTS WERE ALSO DIMMED WHICH DID NOT ASSIST. SURGEON PROCEEDED WITH BIOPSY UTILIZING THE EXISTING TRAJECTORY AND DEPTH SETTINGS. NO PATIENT OR USER HARM. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362247 ↗
• MalfunctionFeb 3, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THAT 3 NEEDLES FROM THE SAME LOT DID NOT SHOW ON THE NAVIGATION. THE SITE USED A DIFFERENT LOT FOR THE 4TH NEEDLE AND IT WORKED PERFECTLY. THE SITE USED THE NEEDLES WITH REGULAR EYE GUIDANCE. NAVIGATION AND IMAGING WERE ABORTED CAUSING LESS THAN AN HOUR DELAY IN THE CASE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13442863 ↗
• MalfunctionDec 15, 2021Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE BIOPSY NEEDLE WAS NOT BEING SEEN BY THE CAMERA. TRAJECTORY WAS LOCKED AND ALL APPROPRIATE STEPS WERE FOLLOWED. THE BIOPSY NEEDLE INSTRUMENT CAME UP ON THE NAVIGATION SCREEN BUT COULD NOT BE SEEN AND WAS RED. THE PATIENT REFERENCE FRAME AND OTHER PROBES WERE TRACKED WITH NO ISSUES. THE BIOPSY STEPS WERE REPLICATED POST-SURGERY AND THE BIOPSY NEEDLE STILL DID NOT SHOW UP. THE SPHERES WERE CLEAN AS WELL AS INSPECTED FOR ANY DAMAGE. THE SPHERES LOOKED NORMAL. THE ISSUE WAS NOT RESOLVED. THE BIOPSY WAS COMPLETED WITHOUT NAVIGATING THE BIOPSY NEEDLE. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010669 ↗
• MalfunctionNov 2, 2021Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY. IT WAS REPORTED THAT DURING A BIOPSY THE USER LOCKED THE TRAJECTORY AND WHEN THEY WENT TO PASS THE NEEDLE, THE NEEDLE WOULD NOT TRACK. THEY HAD THE GUIDE STEM AND CORRECT REDUCING TUBE IN PLACE. THE SPHERES WERE CLEAN AND DRY AND THERE WAS NO VISIBLE DAMAGE. THE MANUFACTURER REPRESENTATIVE OFFERED TO OPEN A NEW NEEDLE FOR THE SURGEON BUT THE SURGEON DECIDED TO NOT TRACK THE NEEDLED INSTEAD OF OPENING ANOTHER ONE. THEY FELT CONFIDENT THAT THE SYSTEM WOULD GUIDE THE NEEDLE CORRECTLY. THE SURGEON COMPLETED THE PROCEDURE AND THEY DID GET DIAGNOSTIC RESULTS BACK. THE ISSUE WAS RESOLVED ON CALL. THERE WAS NO DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738357 ↗
• MalfunctionMar 26, 2021Imprecision; Device Sensing Problem; Imprecision; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A CRANIAL BIOPSY. IT WAS REPORTED THAT THE CRANIAL BIOPSY NEEDLE WAS NOT RECOGNIZED BY THE NAVIGATION SYSTEM. IT WAS REPORTED THAT A SECOND BIOPSY NEEDLE WAS OPENED WITHOUT RESOLUTION. DEPTH OF THE BIOPSY COULD NOT BE MEASURED BY THE NAVIGATION SYSTEM DUE TO THE REPORTEDISSUE. MANUAL MEASUREMENT WAS CONDUCTED AND THE BIOPSY PROCEEDED WITH COLLECTION OF A DIAGNOSTIC SAMPLE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574321 ↗
• MalfunctionNov 20, 2020Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CRANIAL BIOPSY. IT WAS REPORTED THAT AFTER REGISTRATION AND VERIFICATION WITH THE PROBE, WHEN IT WAS TIME TO BRING IN THE BIOPSY NEEDLE, THE CAMERA DID NOT SEE IT. THE SPHERES WERE CLEARLY VISIBLE, THERE WAS NO PRESSURE OF THE REDUCING TUBE, AND THE REFERENCE FRAME WAS ALSO VISIBLE, HOWEVER THE CAMERA STILL WOULD NOT SEE THE NEEDLE. A NEW NEEDLE KIT WAS OPENED, AND THE CAMERA DID NOT SEE THAT NEEDLE EITHER. THIS ISSUE OCCURRED INTRAOPERATIVELY AND DID NOT CAUSE ANY SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PROCEDURE WAS COMPLETED SINCE THE TRAJECTORY HAD ALREADY BEEN MEASURED OUT AND WAS ABLE TO BE MEASURED ON THE NEEDLE, THE SURGEON WAS STILL ABLE TO SAFELY GET TO THE TISSUE HE WANTED TO BIOPSY BY USING THE NEEDLE, HE HOWEVER WAS NOT ABLE TO SEE THE NEEDLE VIA IMAGE GUIDANCE. IT WAS CONFIRMED BOTH NEEDLES WERE INVOLVED IN THE ISSUE. IT WAS NOTED BOTH SPHERES ON BOTH NEEDLES WERE CLEAN, VISIBLE, AND IN THE REDUCING TUBE WITH NO EXTRA PRESSURE OR EXCESSIVE PRESSURE ADDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10876604 ↗
• MalfunctionFeb 17, 2020Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE SCREW ON THE ADJUSTABLE DEPTH COLLAR WOULD NOT TIGHTEN. THE BIOPSY NEEDLE WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9716598 ↗
• MalfunctionDec 3, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A STEREOTACTIC BIOPSY OF THE LEFT CEREBRAL PEDUNCULAR, THE BIOPSY NEEDLE WAS FOUND TO BE DEFECTIVE. IT WAS REPORTED THAT THE DEPTH STOP "PUCK" OF THE UNIT WOULD NOT ENGAGE ON THE NEEDLE WHEN TIGHTENED. IT WAS NOTED THAT THE ISSUE WAS DISCOVERED PRIOR TO USE AND THAT A SECOND NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF FIFTEEN MINUTES DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9403146 ↗
• MalfunctionNov 6, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED PRE-OPERATIVELY OF A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE GRUB SCREW ON THE BLUE WASHER FOR LOCKING THE NEEDLE BIOPSY DISTANCE WAS FAULTY IN THREE DIFFERENT NEEDLES IN THE SAME BATCH. THE INNER THREADS WERE NOT PERFORATED TO ALLOW THE SCREW TO COME THROUGH. THE SITE WAS ABLE TO USE ANOTHER NEEDLE FROM A DIFFERENT BATCH NUMBER TO COMPLETE THE PROCEDURE. THERE WAS A LESS THAN 1-HOUR DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9287553 ↗
• MalfunctionNov 6, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED PRE-OPERATIVELY OF A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE GRUB SCREW ON THE BLUE WASHER FOR LOCKING THE NEEDLE BIOPSY DISTANCE WAS FAULTY IN THREE DIFFERENT NEEDLES IN THE SAME BATCH. THE INNER THREADS WERE NOT PERFORATED TO ALLOW THE SCREW TO COME THROUGH. THE SITE WAS ABLE TO USE ANOTHER NEEDLE FROM A DIFFERENT BATCH NUMBER TO COMPLETE THE PROCEDURE. THERE WAS A LESS THAN 1-HOUR DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9287526 ↗
• MalfunctionNov 6, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE SITE HAD A BIOPSY NEEDLE WHOSE DEPTH STOP WOULD NOT FULLY TIGHTEN DUE TO DAMAGE. IT WAS NOTED THAT THIS WAS AN OUT OF BOX ISSUE AND THAT THE SITE USED A PIECE OF STERILE STRIPPING TO COMPLETE THE CASE. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9284950 ↗
• MalfunctionOct 31, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE REPRESENTATIVE RECEIVED INFORMATION THAT BEFORE A CRANIAL BIOPSY, THE SCREW THREADING ON THE BIOPSY NEEDLE KIT WAS NOT OPERATIONAL, PREVENTING THE KIT FROM CLAMPING (DEFECTIVE DEPTH STOP WOULD NOT LOCK). THE BIOPSY NEEDLE WAS NOT PLACED INTO THE ANATOMY; THE NURSE ATTEMPTED TO LOCK THE DEPTH STOP AND NOTICED THE STOP DID NOT LOCK PRIOR TO THE UNIT BEING INTRODUCED INTO THE ANATOMY. THE SCREW TO SECURE DEPTH STOP ON THE NEEDLE WAS STUCK AND NOT POSSIBLE TO TIGHTEN THE STOP. THEY TOOK ANOTHER NEEDLE AND THE SURGERY WENT OKAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Patient Involvement

  MAUDE report 9261593 ↗
• MalfunctionOct 29, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL BIOPSY. IT WAS REPORTED THAT THE BIOPSY NEEDLE STOPPED WITH BECAUSE OF A SCREW DISFUNCTION. THE HOLE TO WHICH THE SCREW NEEDED TO BE INSERTED WAS NOT DRILLED ALL THE WAY DOWN. THEREFORE THE SCREW COULD NOT BE TIGHTENED TO SECURE THE DEPTH. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9249779 ↗
• MalfunctionOct 22, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT A BIOPSY NEEDLE SCREW WAS NOT FASTENING DOWN TO CREATE AN ACCURATE DEPTH STOP POINT. THE INSTRUMENT WAS SWAPPED WITH ANOTHER ONE THAT WORKED AS INTENDED. THERE WAS NO IMPACT TO PATIENT OUTCOME AND A LESS THAN ONE HOUR DELAY TO THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9218009 ↗
• MalfunctionAug 23, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION DEVICES BEING USED FOR A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE STOP FOR THE BIOPSY NEEDLES DIDN¿T HAVE THREADS ALL THE WAY DOWN WHICH WAS PREVENTING THE SURGEON FROM LOCKING THE STOP. IT WAS NOTED THAT THE ISSUE HAD OCCURRED ON TWO BIOPSY NEEDLES FROM THE SAME LOT. IT WAS NOTED THAT THE SURGEON WAS ABLE TO MAKE IT WORK AND THAT THERE WAS A SURGICAL DELAY OF 5 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8925787 ↗