N/A 9734887XOMRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169488120), received between Dec 27, 2016 and Jul 12, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2025Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE REGISTRATION WAS ON THE WRONG SIDE. THE HEALTH CARE PROFESSIONAL (HCP) DID THE REGISTRATION 3 TIMES. FIRST, THE DOTS OF THE TRACE PATTERN WERE SHOWN ON THE LEFT SIDE OF THE 3-D MODEL. SECOND, THE MANUFACTURER REPRESENTATIVE (REP) TURNED ON PATIENT REFERENCE FRAME AND THEY HAD AN INACCURACY OF 4.4 MM. THIRD, THE REGISTRATION APPEARED AGAIN ON THE WRONG SIDE OF THE HEAD ON A 3-D MODEL. THE HCP TRACED UP AND DOWN AND LEFT TO RIGHT AND THE SYSTEM SHOWED THE DOTS ON THE FRONT OF THE FOREHEAD WHERE THEY WERE SUPPOSED TO BE. THE INACCURACY WAS STILL AT 1.7 MM. VERIFYING THE REGISTRATION ON SPECIFIC LANDMARKS OF THE PATIENT AND THEY WERE STILL OFF BY AT LEAST 5 MM. THE SITE CONTINUED THE PROCEDURE WITHOUT NAVIGATION. THERE WAS NO DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22490263 ↗
• MalfunctionJan 9, 2025Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE NON-INVASIVE PATIENT TRACKER (NIPT) DID NOT FUNCTION WHEN ATTEMPTING TO REGISTER THE PATIENT. THE SITE TRIED ANOTHER NIPT WITH ANOTHER LOT NUMBER, AND THE REPLACEMENT WORKED AS EXPECTED. NO IMPACT ON PATIENT OUTCOME. THE SURGICAL DELAY WAS LESS THAN 1 HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21116486 ↗
• MalfunctionJan 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED PRE-OPERATIVELY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT WHILE REGISTERING, THE POINTS WHERE NOT DRAWN ON THE NOSE, THEY WERE, "SIDLE WO WHERE WE DREW." AFTER REALLY MUCH TRIALS THE ACCURACY WAS AT 1.7 MILLIMETERS (MM) OVERALL AND ABOUT 1 MM IN THE SINUS WHERE THE SITE WANTED TO PERFORM THE SURGERY. BUT IN THE SURGERY WE COULD PROVE THE ACCURACY WITH THE ENDOSCOPE AND IT WAS ABOUT 1 CENTIMETERS (CM). THE CUSTOMER IN THE TRIAL THEN DECIDED TO CHANGE TO HIS OLD NAVIGATION SYSTEM FROM ¿STORZ¿ AND THIS WAS WITHOUT ANY PROBLEM AND WAS ACCURATE. AFTER THREE TIMES OF THIS PROBLEM IN THE OPERATING ROOM (OR) THE SITE DECIDED TO DO A TROUBLESHOOTING AND THEY COULD NOT SEE ANY PROBLEM IN THE OR REGARDING THE TABLE AND THE BREATHING TUBES. THE SITE THEN DECIDED TO DO ANOTHER SURGERY, THIS WENT PERFECTLY WELL W ITHOUT A REGISTRATION ACCURACY PROBLEM. THIS TIME THE TRACKERS WERE FROM ANOTHER CHARGE WITH DIFFERENT BATCH NUMBERS. THE SITE AND FIELD REPRESENTATIVE (REP) DID A RE-EVALUATION AND CAME TO THE CONCLUSION THAT THERE WAS A PROBLEM WITH THE TRACKERS. NO KNOWN IMPACT TO PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085394 ↗
• MalfunctionJan 6, 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 FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT DURING REGISTRATION, THE POINTS WERE NOT DRAWN ON THE NOSE. THEY WERE "SIDLE WO WHERE WE DRAWED." AFTER MANY TRIALS, THE ACCURACY WAS AT 1.7MM OVERALL AND ABOUT 1MM IN THE SINUS WHERE THE HEALTHCARE PROFESSIONAL WANTED TO PERFORM SURGERY. IN THE SURGERY, THEY COULD PROVE THE INACCURACY WITH THE ENDOSCOPE AND IT WAS ABOUT 1CM. THE USE OF THE MEDTRONIC NAVIGATION SYSTEM WAS ABORTED, AND A NAVIGATION SYSTEM FROM ANOTHER MANUFACTURER WAS BROUGHT IN WITHOUT ANY ACCURACY PROBLEMS. AFTER THREE TIMES OF THIS PROBLEM IN THE OPERATING ROOM (OR), TROUBLESHOOTING WAS CONDUCTED WITHOUT ANY ISSUES FOUND. ANOTHER SURGERY WAS PERFORMED WITHOUT ANY REGISTRATION ACCURACY PROBLEMS. HOWEVER, TRACKERS FROM A DIFFERENT LOT WEREUTILIZED. IT WAS SUSPECTED THAT THERE WAS AN ISSUE WITH THE PATIENT TRACKER USED. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. CLARIFICATION WAS LATER RECEIVED IN REGARDS TO THE FOLLOWING STATEMENT, "THEY WERE 'SIDLE WO WHERE WE DRAWED.'" POINTS WERE COLLECTED OUTSIDE ON THE WHOLE NOSE. IN THE 3D MODEL, THE POINTS WERE DRAW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21084315 ↗
• MalfunctionDec 11, 2024Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT DURING REGISTRATION THEY ACQUIRED A 1.8 REGISTRATION ACCURACY; HOWEVER, THE ACCURACY WAS OFF AND SHOWING THE INSTRUMENT IN THE ANATOMY WHEN THE INSTRUMENT WAS ON THE SURFACE OF THE SKIN. THE HEALTHCARE PROVIDER (HCP) VERIFIED THE PATIENT TRACKERS WERE NOT FROM THE LIST OF LOT NUMBERING FAILING TO VERIFY. THE MEDTRONIC REPRESENTATIVE (REP) SWITCHED TO ANOTHER SCAN AND THE ACCURACY WAS AT 1.5 AND TRACKING CORRECTLY. THERE WAS LESS THAN ONE HOUR OF DELAY AND THIS HAD NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. THE REGISTRATION SEEMED TO BE EMBEDDED WITHIN THE PATIENT, WHICH WAS SUSPECTED TO BE WHY THE NAVIGATION WAS OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904931 ↗
• MalfunctionSep 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS.) IT WAS REPORTED THAT THERE WAS AN INACCURACY OF 1.7MM WHILE REGISTERING WHEN USING A NON-INVASIVE PATIENT TRACKER (NIPT.) WHEN THE MANUFACTURER REPRESENTATIVE (REP) WAS ASKED WHAT THE FOLLOWING STATEMENT MEANT, CLARIFICATION WAS RECEIVED, "DURING REGISTRATION, THE POINTS WERE NOT DRAWN ON THE NOSE, BUT THEY WERE "SIDLY" TO EVERYWHERE THEY DREW." THE COLLECTED POINTS WERE SHOWN ON ONE SIDE OF THE NOSE EVEN THOUGH THE POINTS THAT WERE COLLECTED WERE ON THE BRIDGE OF THE NOSE. THE POINTS COLLECTED ON THE OTHER SIDE WEREN'T SHOWN AT ALL ON THE 3D MODEL. IT WAS SUSPECTED THEY WERE DREW ON THE INSIDE OF THE NOSE. AFTER MUCH TESTING AND TRIALS, THE ACCURACY WAS AT 1.7MM OVERALL AND ABOUT 1MM IN THE SINUS WHERE THEY WANTED TO PERFORM SURGERY. IN SURGERY THEY COULD PROVE THE ACCURACY WITH AN ENDOSCOPE, AND THE ACCURACY WAS ABOUT 1CM. THE ACCURACY OVERALL WAS CALCULATED FROM THE SYSTEM TO 1.7MM REGISTRATION ACCURACY AFTER THE REGISTRATION. IN SOME POINTS THIS NEARLY MATCHED, BUT IN OTHER POINTS THIS WAS NOT CORRECT AT ALL. THEY WERE SAFE AT THE SKULL BASE AND HAD NAVIG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232790 ↗
• MalfunctionSep 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS.) IT WAS REPORTED THAT THERE WAS AN INACCURACY OF 1.7MM WHILE REGISTERING WHEN USING A NON-INVASIVE PATIENT TRACKER (NIPT.) WHEN THE MANUFACTURER REPRESENTATIVE (REP) WAS ASKED WHAT THE FOLLOWING STATEMENT MEANT, CLARIFICATION WAS RECEIVED, "DURING REGISTRATION, THE POINTS WERE NOT DRAWN ON THE NOSE, BUT THEY WERE "SIDLY" TO EVERYWHERE THEY DREW." THE COLLECTED POINTS WERE SHOWN ON ONE SIDE OF THE NOSE EVEN THOUGH THE POINTS THAT WERE COLLECTED WERE ON THE BRIDGE OF THE NOSE. THE POINTS COLLECTED ON THE OTHER SIDE WEREN'T SHOWN AT ALL ON THE 3D MODEL. IT WAS SUSPECTED THEY WERE DREW ON THE INSIDE OF THE NOSE. AFTER MUCH TESTING AND TRIALS, THE ACCURACY WAS AT 1.7MM OVERALL AND ABOUT 1MM IN THE SINUS WHERE THEY WANTED TO PERFORM SURGERY. IN SURGERY THEY COULD PROVE THE ACCURACY WITH AN ENDOSCOPE, AND THE ACCURACY WAS ABOUT 1CM. THE ACCURACY OVERALL WAS CALCULATED FROM THE SYSTEM TO 1.7MM REGISTRATION ACCURACY AFTER THE REGISTRATION. IN SOME POINTS THIS NEARLY MATCHED, BUT IN OTHER POINTS THIS WAS NOT CORRECT AT ALL. THEY WERE SAFE AT THE SKULL BASE AND HAD NAVIG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232771 ↗
• MalfunctionSep 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS.) IT WAS REPORTED THAT THERE WAS AN INACCURACY OF 1.7MM WHILE REGISTERING WHEN USING A NON-INVASIVE PATIENT TRACKER (NIPT.) WHEN THE MANUFACTURER REPRESENTATIVE (REP) WAS ASKED WHAT THE FOLLOWING STATEMENT MEANT, CLARIFICATION WAS RECEIVED, "DURING REGISTRATION, THE POINTS WERE NOT DRAWN ON THE NOSE, BUT THEY WERE "SIDLY" TO EVERYWHERE THEY DREW." THE COLLECTED POINTS WERE SHOWN ON ONE SIDE OF THE NOSE EVEN THOUGH THE POINTS THAT WERE COLLECTED WERE ON THE BRIDGE OF THE NOSE. THE POINTS COLLECTED ON THE OTHER SIDE WEREN'T SHOWN AT ALL ON THE 3D MODEL. IT WAS SUSPECTED THEY WERE DREW ON THE INSIDE OF THE NOSE. AFTER MUCH TESTING AND TRIALS, THE ACCURACY WAS AT 1.7MM OVERALL AND ABOUT 1MM IN THE SINUS WHERE THEY WANTED TO PERFORM SURGERY. IN SURGERY THEY COULD PROVE THE ACCURACY WITH AN ENDOSCOPE, AND THE ACCURACY WAS ABOUT 1CM. THE ACCURACY OVERALL WAS CALCULATED FROM THE SYSTEM TO 1.7MM REGISTRATION ACCURACY AFTER THE REGISTRATION. IN SOME POINTS THIS NEARLY MATCHED, BUT IN OTHER POINTS THIS WAS NOT CORRECT AT ALL. THEY WERE SAFE AT THE SKULL BASE AND HAD NAVIG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232371 ↗
• MalfunctionAug 28, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE NON-INVASIVE PATIENT TRACKER (NIPT) WAS NOT COMMUNICATING AND WOULD NOT CONNECT TO THE NAVIGATION SYSTEM. ANOTHER NIPT WAS USED AND WORKED WITHOUT ISSUE. THERE WAS NO REPORTED IMPACT TO THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE BEING PERFORMED WAS A TRANSSPHENOIDAL PITUITARY TUMOR RESECTION WITH ELECTR OMAGNETIC (EM) NAVIGATION. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086799 ↗
• MalfunctionJan 17, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY. IT WAS REPORTED THAT THIS SYSTEM WAS UNABLE TO VERIFY THE REGISTRATION PROBE DURING A CASE. THERE WAS NO IMPACT ON PATIENT OUTCOME REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A DELAY OF 5-10 MINUTES. THE PROCEDURE WAS COMPLETED BY SWITCHING TO DIFFERENT TRACKERS AND WERE ABLE TO VERIFY THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531620 ↗
• MalfunctionJul 13, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE PATIENT TRACKER COULD BE CONNECTED TO THE BREAK OUT BOX, BUT THE SYSTEM COULDN'T PICK UP THE SIGNAL. IT SHOWED A RED COLOR, EVEN AFTER THEY TRIED TO REBOOT AND RELOCATE THE EMITTER. THE SITE USED BACKUP TRACKER TO COMPLETE THE PROCEDURE. THE USE OF MEDTRONIC NAVIGATION WAS ABORTED. THERE WAS A DELAY OF ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315892 ↗
• MalfunctionApr 30, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A NAVIGATION SYSTEM OUTSIDE OF A PROCEDURE. THE CONTACT REPORTED THAT THE SITE WAS HAVING ISSUES WITH A PATIENT TRACKER BEING UNABLE TO TRACK. THE CONTACT INDICATED THAT THE ISSUE WAS NOTICED ON DECEMBER 05, 2018, BUT THE SITE DID NOT REPORT THE ISSUE TO THE REP UNTIL APRIL 25, 2019. THERE WAS NO PATIENT INVOLVED WITH THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8564755 ↗
• MalfunctionApr 16, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT WOULD NOT VERIFY. THE SITE USED A NEW INSTRUMENT AND PROCEEDED WITH THE CASE. THERE WAS NO REPORTED DELAY TO PROCEDURE AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8519203 ↗
• MalfunctionApr 1, 2019Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SITE WAS USING A PATIENT TRACKER THEY VERIFIED THE INSTRUMENT, REGISTERED, AND THEN WHEN THEY GOT TO NAVIGATE, THE TRACKER SHOWED RED STATUS. THEY MOVED THE EMITTER, CHECKED FOR METAL, ALL WITH NO RESOLUTION. THEY REBOOTED THE SYSTEM STILL WITHOUT RESOLUTION. AT THIS POINT, THEY PLACED A NEW PATIENT TRACKER ON, VERIFIED INSTRUMENTS, REGISTERED, AND WENT TO NAVIGATE WITHOUT ISSUE. NOTHING ELSE HAD CHANGED IN THE ENVIRONMENT. THERE WAS LESS THAN AN HOUR DELAY IN THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8468945 ↗
• MalfunctionJan 30, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE THE SITE REGISTERED THE PATIENT, BUT WHEN THEY MOVED TOWARD THE NAVIGATE SCREEN THE PATIENT TRACKER WAS NOT VISIBLE IN THE TRACKING VIEW, BUT A STYLET WAS VISIBLE WHEN THEY BROUGHT IT IN THE FIELD OF VIEW. THE CASE CONTINUED WITHOUT NAVIGATION. THERE WAS NO PATIENT IMPACT REPORTED AND THE DELAY IN SURGERY WAS LESS THAN AN HOUR. SURGERY PROCEEDED AS PLANNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7228631 ↗
• MalfunctionDec 27, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING AN EAR, NOSE, AND THROAT PROCEDURE, A SUCTION INSTRUMENT WAS UNABLE TO BE RECOGNIZED BY THE NAVIGATION SYSTEM. IT WAS REPORTED THAT REGISTRATION WAS SUCCESSFULLY COMPLETED, BUT WHEN THE SURGEON ATTEMPTED TO USE THE STRAIGHT SUCTION INSTRUMENT WITH AN INSTRUMENT TRACKER, THE SOFTWARE DID NOT RECOGNIZE IT. THE EMITTER POSITION WAS ADJUSTED AND THE SYSTEM WAS REBOOTED, NEITHER OF WHICH RESOLVED THE ISSUE. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS NOT IMPACTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6206978 ↗