N/A 9733068 (UDI 00643169546820)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169546820), received between Oct 17, 2016 and Apr 29, 2019 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY PROCEDURE. THE ISSUE OCCURRED POST INCISION, AFTER ANESTHESIA HAD BEEN ADMINISTERED AND CAUSED DELAY TO THE SURGERY. IT WAS REPORTED THAT THE SYSTEM DID NOT TRACK THE LOCATION OF THE PASSIVE BIOPSY NEEDLE; THUS IT WAS NOT POSSIBLE TO NAVIGATE IT. THE ISSUE WAS RESOLVED BY REPLACING THE PASSIVE BIOPSY NEEDLE WITH A NEW ONE. THE SURGERY WAS COMPLETED WITH NAVIGATION. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8562570 ↗
• MalfunctionOct 24, 2018Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL BIOPSY. IT WAS REPORTED THAT THE SITE WAS HAVING ISSUES TRACKING THE BIOPSY NEEDLES. MULTIPLE HEALTH CARE PROFESSIONALS (HCP) ATTEMPTED TO TROUBLE SHOOT THE ISSUE BUT NOTHING RESOLVED THE ISSUE, THE SITE TRIED USING ANOTHER BIOPSY NEEDLE BUT THAT ONE DIDN¿T WORK EITHER. THE SITE DECIDED TO ADVANCE THE NEEDLE TO BIOPSY WITHOUT LIVE TRACKING UPDATE OF THE NEEDLE POSITION, OPTING TO FOLLOW THE PLAN AND THE GUIDE STOP MEASUREMENT CALCULATED FROM THE TARGETING ASPECT OF THE PROCEDURE. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8001637 ↗
• MalfunctionAug 11, 2017Communication or Transmission Problem; Device Operates Differently Than Expected; Communication or Transmission Problem; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL BIOPSY, THE BIOPSY NEEDLE COULD NOT BE OBSERVED IN THE APPLICATION SOFTWARE THOUGH TARGETING COULD BE ACCOMPLISHED. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM FOR DEPTH MEASUREMENT. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6789716 ↗
• MalfunctionApr 19, 2017Communication or Transmission Problem; Device Operates Differently Than Expected; Communication or Transmission Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL BIOPSY, THE BIOPSY NEEDLE WOULD NOT TRACK WHEN PLACED WITHIN THE REDUCING TUBE OF THE BIOPSY SET. THE SITE OPENED ANOTHER BIOPSY NEEDLE AND WERE ABLE TO TRACK THE INSTRUMENT WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6503545 ↗
• MalfunctionApr 5, 2017Communication or Transmission Problem; Device Operates Differently Than Expected; Communication or Transmission Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL BIOPSY PROCEDURE, THE BIOPSY NEEDLE WAS NOT SEEN BY THE NAVIGATION SYSTEM. THEY CONFIRMED THAT THE TRAJECTORY WAS LOCKED WITH NOBODY WAS TOUCHING THE INSTRUMENT. THEY ALSO CONFIRMED THAT THE BIOPSY NEEDLE WAS SELECTED FOR THE PROCEDURE. REPEATED LOCKING PROCEDURE WITH NO RESOLUTION. THE SURGEON PROCEEDED WITHOUT NAVIGATION AND WAS ABLE TO RETRIEVE 2 VIABLE SPECIMENS FOR PATHOLOGY. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6461206 ↗
• MalfunctionFeb 24, 2017Communication or Transmission Problem; Communication or Transmission Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL BIOPSY PROCEDURE, AFTER THE TRAJECTORY WAS LOCKED, THE BIOPSY NEEDLE WOULD NOT TRACK. THIS HAPPENED TWICE. THE MEDTRONIC REPRESENTATIVE WAS CONFIDENT THE CAMERA COULD SEE BOTH SPHERES ON THE CAMERA. THE SURGEON OPTED TO DISCONTINUE NAVIGATING THE BIOPSY NEEDLE, HOWEVER, STILL USED IT TO EXTRACT A SAMPLE. NO FURTHER DETAILS REGARDING THE BEHAVIOR, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6358865 ↗
• MalfunctionFeb 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE, FOLLOWING UP WITH THE SITE, REPORTED THAT THE BIOPSY NEEDLE WAS DIFFICULT TO SLIDE IN AND OUT DURING BIOPSY COLLECTION. THE SCREW ON THE REDUCING TUBE WAS TIGHTENED TOO FAR WHICH CAUSED THE ISSUE MOVING THE BIOPSY NEEDLE. THE CASE WAS COMPLETED USING THE BIOPSY NEEDLE. IMMEDIATELY AFTER THE CASE, THE SITE DISCARDED THE BIOPSY NEEDLE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6326902 ↗
• MalfunctionFeb 10, 2017Complete Blockage; Device Operates Differently Than Expected; Complete Blockage; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A CASE, THEY WERE UNABLE TO FLUSH OUT THE BIOPSY NEEDLE. THEY OPENED ANOTHER NEEDLE TO COMPLETE THE CASE. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6322159 ↗
• MalfunctionJan 13, 2017Communication or Transmission Problem; Material Deformation; Communication or Transmission Problem; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL BIOPSY PROCEDURE, THE SURGEON ALLEGED THAT THE BIOPSY NEEDLE WAS DAMAGED AND THE SPHERES MOVED. THE SURGEON WAS INSERTING THE BIOPSY NEEDLE AND USED "EXCESSIVE" FORCE TO INSERT THE NEEDLE. AT THAT TIME THE SPHERES MOVED AND IT INDICATED THE BIOPSY NEEDLE WAS FARTHER THAN IT ACTUALLY WAS IN THE SOFTWARE. A NEW BIOPSY NEEDLE WAS BROUGHT IN TO BE USED IN CONTINUING THE PROCEDURE. THE SURGEON OBTAINED A POSITIVE SAMPLE WITH THE NEW BIOPSY NEEDLE. DELAY IN THERAPY WAS 10 MINUTES. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6252072 ↗
• MalfunctionOct 17, 2016Complete Blockage; Complete Blockage

  A SITE REPRESENTATIVE REPORTED THAT, WHILE PREPPING FOR A BIOPSY PROCEDURE THE BIOPSY NEEDLE WAS OBSTRUCTED. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THE SURGEON WAS ABLE TO CONTINUE THE PROCEDURE WITH A DIFFERENT NEEDLE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6033281 ↗