AxiEM™ 9733533XOMRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00763000588342), received between May 23, 2022 and Mar 23, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (22 reports).

28 other recalls cover devices cleared under the same FDA submission (K001284); 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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT NONE OF THE DISPOSABLES WERE WORKING AND THE SURGEON COULDN'T TRACE/TRACK INSTRUMENTS. THEY SWITCHED NAVIGATION SYSTEMS AND THEN TWO OF EACH INSTRUMENT AND PATIENT TRACKERS AND THEN THEY FINALLY GOT THE SYSTEM WORKING. IT WAS UNKNOWN IF THE PRODUCT WAS DAMAGED. THIS ISSUE CAUSED A 20 MINUTE SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. IT WAS REPORTED THAT THE PROCEDURE WAS A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THEY USED BOTH OF THEIR SYSTEMS AND TRIED MULTIPLE DIFFERENT TRACKERS. IT WAS LIKELY A MIX OF USER ERROR, POTENTIAL DISPOSABLE FAULTS AND EVENTUALLY THEY FOUND THE RIGHT COMBINATION OF PRODUCTS AND EVERYTHING BEGAN WORKING. REGARDING SEEING THE INSTRUMENTS IN THE TRACKING WINDOW: "WE COULD NOT GET THEM GREEN STATUS. THEY WERE RED STATUS BOTH THE INSTRUMENT AND PATIENT TRACKER. THE INSTRUMENT WOULD COME IN AND OUT, BUT IT WOULDN¿T CALIBRATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663278 ↗
• MalfunctionMar 23, 2026Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT NONE OF THE DISPOSABLES WERE WORKING AND THE SURGEON COULDN'T TRACE/TRACK INSTRUMENTS. THEY SWITCHED NAVIGATION SYSTEMS AND THEN TWO OF EACH INSTRUMENT AND PATIENT TRACKERS AND THEN THEY FINALLY GOT THE SYSTEM WORKING. IT WAS UNKNOWN IF THE PRODUCT WAS DAMAGED. THIS ISSUE CAUSED A 20 MINUTE SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE WAS A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THEY USED BOTH OF THEIR SYSTEMS AND TRIED MULTIPLE DIFFERENT TRACKERS. IT WAS LIKELY A MIX OF USER ERROR, POTENTIAL DISPOSABLE FAULTS AND EVENTUALLY THEY FOUND THE RIGHT COMBINATION OF PRODUCTS AND EVERYTHING BEGAN WORKING. REGARDING SEEING THE INSTRUMENTS IN THE TRACKING WINDOW: "WE COULD NOT GET THEM GREEN STATUS. THEY WERE RED STATUS BOTH THE INSTRUMENT AND PATIENT TRACKER. THE INSTRUMENT WOULD COME IN AND OUT, BUT IT WOULDN¿T CALIBRATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663265 ↗
• MalfunctionMay 16, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT UPON TRYING TO REGISTER THAT PATIENT, THE SYSTEM WAS UNABLE TO TRACK. THE REGISTRATION PROBE WAS NOT SEEN ON THE SYSTEM, THEY TRIED MULTIPLE PORTS ON THE BREAK OUT BOX (BOB) WITH THE SAME OUTCOME. THEY SWITCHED TO NEW CABLE AND CONTINUED WITH THE PROCEDURE. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035114 ↗
• MalfunctionMar 11, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT TRACKER WOULD NOT WORK DURING THE PROCEDURE. THEY IMMEDIATELY SWITCHED IT OUT WITH A NEW TRACKER AND IT WORKED FINE. THERE WAS NO IMPACT TO PATIENT'S OUTCOME AND THERE WAS NO SURGICAL DELAY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576737 ↗
• MalfunctionMar 5, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT TRACKERS WERE NOT TRACKING AND HAD A GEOMETRY ERROR OF >1 MM. AFTER VERIFYING THE STRAIGHT SUCTION, THEY WENT TO VERIFY THE CURVED SUCTIONS AND ALL 3 INSTRUMENT TRACKERS SHOWED AS RED IN THE TRACKING DETAILS AND THE ONLY THING THAT WAS GREEN WAS THE NON-INVASIVE PATIENT TRACKER (NIPT), WHICH HAD A GEOMETRY ERROR OF 0.8MM. PORTS ON THE BREAK OUT BOX (BOB) WERE GREEN EXCEPT FOR PORT 4, WHICH DID NOT HAVE AN LED WHEN AN INSTRUMENT TRACKER WAS PLUGGED INTO IT; THEY TAPPED THE BOB AND IT TURNED GREEN AFTER THAT. THEY REPORTED THERE WAS NO METAL IN FIELD AND THERE WAS A 3 INCH PAD BETWEEN THE PATIENT AND THE BED. IT WAS NOTED THAT THE "EM FIELD SEEMED SMALLER THAN USUAL" AND REPORTED THE TRACKING ISSUES WOULD OCCUR WHEN THEY WERE ABOUT 12 INCHES ABOVE THE FLAT EMITTER. THEY REBOOTED THE SYSTEM AND REMOVED THE DONUT FROM UNDER THE PATIENT AND THE INSTRUMENTS SHOWED UP IN THE T RACKING WINDOW, THE INSTRUMENT TRACKERS AND NIPT GEOMETRY ERROR DROPPED TO 0.6 MM, BUT THE INSTRUMENT TRACKERS WOULD FLICKER RED WHEN THEY REACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526757 ↗
• MalfunctionMar 5, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT TRACKERS WERE NOT TRACKING AND HAD A GEOMETRY ERROR OF >1 MM. AFTER VERIFYING THE STRAIGHT SUCTION, THEY WENT TO VERIFY THE CURVED SUCTIONS AND ALL 3 INSTRUMENT TRACKERS SHOWED AS RED IN THE TRACKING DETAILS AND THE ONLY THING THAT WAS GREEN WAS THE NON-INVASIVE PATIENT TRACKER (NIPT), WHICH HAD A GEOMETRY ERROR OF 0.8MM. PORTS ON THE BREAK OUT BOX (BOB) WERE GREEN EXCEPT FOR PORT 4, WHICH DID NOT HAVE AN LED WHEN AN INSTRUMENT TRACKER WAS PLUGGED INTO IT; THEY TAPPED THE BOB AND IT TURNED GREEN AFTER THAT. THEY REPORTED THERE WAS NO METAL IN FIELD AND THERE WAS A 3 INCH PAD BETWEEN THE PATIENT AND THE BED. IT WAS NOTED THAT THE "EM FIELD SEEMED SMALLER THAN USUAL" AND REPORTED THE TRACKING ISSUES WOULD OCCUR WHEN THEY WERE ABOUT 12 INCHES ABOVE THE FLAT EMITTER. THEY REBOOTED THE SYSTEM AND REMOVED THE DONUT FROM UNDER THE PATIENT AND THE INSTRUMENTS SHOWED UP IN THE T RACKING WINDOW, THE INSTRUMENT TRACKERS AND NIPT GEOMETRY ERROR DROPPED TO 0.6 MM, BUT THE INSTRUMENT TRACKERS WOULD FLICKER RED WHEN THEY REACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526602 ↗
• MalfunctionFeb 19, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE PATIENT TRACKER WAS TRACKING INITIALLY ON ITS OWN, BUT ANY TIME THE INSTRUMENT WAS BROUGHT INTO THE FIELD, IT WOULD NOT TRACK, AND THE INSTRUMENT TRACKER WOULD SHOW AS RED. THE MANUFACTURER REPRESENTATIVE PLUGGED THE INSTRUMENT INTO A DIFFERENT PORT WITH NO RESOLUTION. THEY USED A NEW TRACKER AND THE ISSUE WAS RESOLVED. IT WAS NOTED THAT THIS WAS AN OUT OF BOX FAILURE. THERE WAS NO DELAY TO THE PROCEDURE AND NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407332 ↗
• MalfunctionDec 13, 2024Device Sensing Problem; Human-Device Interface Problem; Application Program Freezes or Fails to Launch; Device Sensing Problem; Human-Device Interface Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAD A LOW PERFORMANCE ERROR WHILE ATTEMPTING TO REGISTER THE PATIENT. THE INSTRUMENT TRACKER WAS NOT CONSISTENTLY FUNCTIONAL. THE MEDTRONIC REPRESENTATIVE (REP) HAD THE CUSTOMER REBOOT THE SYSTEM WHICH RESULTED IN SUCCESS WITH THE INSTRUMENT TRACKER AND REGISTRATION WITHOUT ADDITIONAL ERRORS. AFTER THE SYSTEM REBOOT, THE PATIENT TRACKER DID NOT WORK CORRECTLY. THEY TRIED RESEATING THE PATIENT TRACKER, BUT THE ISSUE DID NOT RESOLVE. THE SITE HAD TO SWITCH PATIENT TRACKERS FOR A SUCCESSFUL REGISTRATION. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926046 ↗
• MalfunctionDec 13, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A NON-INVASIVE PATIENT TRACKER (NIPT). THE TRACKER REMAINED RED IN THE TRACKING VIEW. UPON CHECKING THE GEOMETRY VALUE, THE MEDTRONIC REPRESENTATIVE (REP) NOTICED IT WAS APPROXIMATELY 192, WHICH WAS UNUSUALLY HIGH. THE SITE SWAPPED TO A NEW NIPT, AND THE ISSUE WAS RESOLVED. 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 20925392 ↗
• MalfunctionDec 11, 2024Device Sensing Problem; Human-Device Interface Problem; Device Sensing Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THE SITE WAS HAVING ISSUES REGISTERING. AFTER SUCCESSFULLY REGISTERING AT 2.3MM, THE STRAIGHT SUCTION WOULD NOT VERIFY. THE EAR, NOSE/THROAT (ENT) TRACKER ON THE STRAIGHT SUCTION WOULD NOT GO BELOW 3.5MM. THE SITE HAD USED A TOTAL OF TWO ENT TRACKERS THAT WOULD NOT GO BELOW 3.5MM. AT FIRST THEY DID NOT ADD THE STRAIGHT SUCTION TO THE EQUIPMENT LIST AS WELL. TROUBLESHOOTING WAS DONE AND TECHNIQUE WAS BAD AT FIRST. TECHNICAL SERVICES (TS) HAD THE SITE START AT THE TIP OF THE NOSE AND ONLY TRACE ON THE HARD SURFACES AND THAT GAVE THEN A SUCCESSFUL REGISTRATION. THE OTHER REGISTRATIONS WERE NOT ACCURATE IN VERIFY ACCURACY (5.0 MM, 6.2 MM, 4.2 MM,4.1 MM) AND THE LINES WERE NOT ON THE NOSE OR THE FOREHEAD THEY WERE ON THE CHEEKS AND EYES. THE POINTS LOOKED SUNK IN AS WELL. TS NOTICED THIS DUE TO THE YELLOW CIRCLE OF ACCURACY SHOWING UP BEHIND THE NOSE AREA. AFTER THE DOCTOR TRACED LIGHTER AND STAYED ON THE HARD SURFACES ACCURACY WAS AT 2.3MM. THE IMAGE HAD MOST OF THE FOREHEAD GONE AS WELL. TS HAD TO CHANGE THEM TO TRACE. THEY WERE ORIGINALLY ON PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906110 ↗
• MalfunctionDec 11, 2024Device Sensing Problem; Human-Device Interface Problem; Device Sensing Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THE SITE WAS HAVING ISSUES REGISTERING. AFTER SUCCESSFULLY REGISTERING AT 2.3MM, THE STRAIGHT SUCTION WOULD NOT VERIFY. THE EAR, NOSE <(>&<)> THROAT (ENT) TRACKER ON THE STRAIGHT SUCTION WOULD NOT GO BELOW 3.5MM. THE SITE HAD USED A TOTAL OF TWO ENT TRACKERS THAT WOULD NOT GO BELOW 3.5MM. AT FIRST THEY DID NOT ADD THE STRAIGHT SUCTION TO THE EQUIPMENT LIST AS WELL. TROUBLESHOOTING WAS DONE AND TECHNIQUE WAS BAD AT FIRST. TECHNICAL SERVICES (TS) HAD THE SITE START AT THE TIP OF THE NOSE AND ONLY TRACE ON THE HARD SURFACES AND THAT GAVE THEN A SUCCESSFUL REGISTRATION. THE OTHER REGISTRATIONS WERE NOT ACCURATE IN VERIFY ACCURACY (5.0 MM, 6.2 MM, 4.2 MM,4.1 MM) AND THE LINES WERE NOT ON THE NOSE OR THE FOREHEAD THEY WERE ON THE CHEEKS AND EYES. THE POINTS LOOKED SUNK IN AS WELL. TS NOTICED THIS DUE TO THE YELLOW CIRCLE OF ACCURACY SHOWING UP BEHIND THE NOSE AREA. AFTER THE DOCTOR TRACED LIGHTER AND STAYED ON THE HARD SURFACES ACCURACY WAS AT 2.3MM. THE IMAGE HAD MOST OF THE FOREHEAD GONE AS WELL. TS HAD TO CHANGE THEM TO TRACE. THEY WERE ORIGINALLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906097 ↗
• 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 20904617 ↗
• MalfunctionNov 7, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY. IT WAS REPORTED THAT BOTH TRACKERS WOULD NOT TRACK. NEW TRACKERS WERE USED AND WERE ABLE TO TRACK. THERE WAS A DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630411 ↗
• MalfunctionNov 7, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE INSTRUMENT TRACKER WAS PLUGGED IN BUT WAS NOT VERIFYING ON PATIENT TRACKER. THE LIGHT ON THE EMITTER BOX WAS GREEN BUT WHEN THE REPRESENTATIVE OPENED THE TRACKING DETAILS IT LISTED THE INSTRUMENT TRACKER AS INSTALLING AND WAS IN YELLOW. THE REPRESENTATIVE MOVED TO A DIFFERENT PORT BUT GOT THE SAME RESULT. THE STAFF GRABBED A NEW INSTRUMENT TRACKER AND CONTINUED WITH THE CASE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND NO REPORTED DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630358 ↗
• MalfunctionNov 7, 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 THE INSTRUMENT TRACKER WAS HAVING DIFFICULTY BEING TRACKED WHILE IN THE SINUS. IT WAS DIFFICULT TO VERIFY THE TRACKER AS WELL. THEY HAD TO OPEN UP A NEW TRACKER TO REPLACE THE ONE THAT WASN'T TRACKING. THERE WAS A DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630325 ↗
• MalfunctionNov 7, 2024Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SI NUS SURGERY (FESS). IT WAS REPORTED THAT THE INSTRUMENT TRACKER WAS ATTACHED TO THE 70 DEGREE SUCTION. THE TIP OF THE SUCTION WAS PLACED IN THE DIVOT ON THE PATIENT TRACKER TO VERIFY. THE FUSION WAS NOT DETECTING THE TRACKER AT ALL. TRIED SEVERAL TIMES AND THEN SWITCHED TO A DIFFERENT INSTRUMENT TRACKER. THE NEW ONE WAS DETECTED ON THE SCREEN AND EVENTUALLY REGISTERED THE INSTRUMENT. THIS CAUSED LESS THAN ONE HOUR OF DELAY AND HAD NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630039 ↗
• MalfunctionNov 7, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN PLUGGING THE PATIENT TRACKER INTO THE ELECTROMAGNETIC NAVIGATION INTERFACE UNIT, THE LIGHT STAYED AMBER, BUT WHEN PLUGGING IN ANOTHER INSTRUMENT TRACKER ONTO THE SAME PORT, THE PORT TURNED GREEN AND THE SITE WAS ABLE TO CONTINUE WITH THE SURGERY. THIS WAS DISCOVERED BEFORE PATIENT WAS IN THE ROOM, SO THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE LIKELY CAUSE OF THIS ISSUE WAS A MANUFACTURING DEFECT, OUT-OF-THE-BOX FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629199 ↗
• MalfunctionMay 17, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE TRACKER  WAS WORKING FOR ABOUT HALF OF THE CASE THEN STOPPED TACKING. ALL THE INPUTS WERE CHECKED AND ADDITIONAL POSSIBLE INTERFERENCE. THE ONLY RESOLUTION WAS TO CHANGE THE TRACKER. THERE WAS NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345811 ↗
• MalfunctionMay 2, 2024

  DID NOT REGISTER INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229451 ↗
• MalfunctionJun 30, 2023Imprecision; Device Sensing Problem; Imprecision; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED INTRAOPERATIVELY IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) IN WHICH THERE WAS PATIENT INVOLVEMENT. IT WAS REPORTED THAT A PATIENT WAS REGISTERED WITHOUT ISSUE AND NAVIGATION LOOKED ACCURATE IN VERIFY REGISTRATION TASK. THE STRAIGHT SUCTION WAS VERIFIED WITHOUT ISSUE BUT THE SYSTEM WAS NOT ABLE TO RECOGNIZE THAT THEIR CURVED SUCTION WAS ATTEMPTING TO VERIFY ON THE SAME INSTRUMENT TRACKER. THE INSTRUMENT TRACKER WAS SWAPPED AND WERE THEN ABLE TO VERIFY BOTH THE STRAIGHT AND CURVED SUCTIONS WITHOUT ISSUE. AFTER RESOLVING THAT ISSUE, THE SURGEON REPORTEDLY FELT INACCURATE. NAVIGATIONAL ACCURACY WAS NOT ABLE TO BE RE-ESTABLISHED. NAVIGATION WAS ABORTED. SURGICAL DELAY WAS REPORTED AS LESS THAN ONE HOUR AND THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237367 ↗
• MalfunctionMar 1, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PATIENT TRACKER WAS NOT CONNECTING TO THE SYSTEM TO TRACK AND IT WOULD NOT VERIFY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16462452 ↗
• MalfunctionJan 26, 2023Device Sensing Problem; Application Program Freezes or Fails to Launch; Device Sensing Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SYSTEM POPULATED, " LOCALIZER NOT CONNECTED " INITIALLY, RESEATING THE CABLE A FEW TIMES HELPED RE-ESTABLISH THAT CONNECTION. THE SITE CALLED BACK AND REPORTED NOW THAT WHEN IN REGISTRATION, THE ERROR "INSTRUMENT NOT VERIFIED" POPULATED, AND THE SITE WAS UNABLE TO VERIFY THE REGISTRATION PROBE. THE SITE SWAPPED OUT MULTIPLE INSTRUMENT TRACKERS. THE TRACKING DETAILS REVEALED THAT ALL FOUR INSTRUMENT'S STATUS WAS "CONNECTED' AND ALL GREEN. ALL INSTRUMENTS WERE SHOWING IN THE TRACKING VIEW. TECHNICAL SERVICES TRIED TO HAVE THE SITE SWAP TO ANOTHER NON-INVASIVE PATIENT TRACKER, BUT THE SURGEON HAD ALREADY MOVED ON WITHOUT USING THE SYSTEM. MEDTRONIC IMAGING AND NAVIGATION WERE ABORTED. THIS OCCURRED INTRAOPERATIVELY, AND THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250871 ↗
• MalfunctionDec 20, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS ISSUES WITH SEVERAL TRACKABLE INSTRUMENTS BEING RECOGNIZED BY THE SYSTEM. WHEN PLUGGED IN, THE SITE GOT A GREEN INDICATION THAT THE SYSTEM READ THE INSTRUMENT. HOWEVER, TRACKING DETAILS DID NOT SHOW THE INSTRUMENT, AND THE PATIENT TRACKER WAS BETWEEN .5 AND .7. THERE WAS NO PATIENT INVOLVEMENT, (B)(6) 2022. NO TROUBLESHOOTING / MANUAL WORKAROUND RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017952 ↗
• MalfunctionMay 23, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRAOPERATIVELY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE PATIENT WAS ABLE TO BE REGISTERED BY TRACE METHOD WITHOUT ANY ISSUES. ONCE THE INSTRUMENT TRACKER WAS MOVED TO THE STRAIGHT SUCTION, IT WAS VERIFIED IN THE DIVOT OF THE NON-INVASIVE PATIENT TRACKER WITHOUT ISSUE. HOWEVER, THE STRAIGHT SUCTION FAILED TO NAVIGATE WITHIN THE ELECTROMAGNETIC (EM) FIELD. THE DISPLAY WAS STATIC AND THE CROSS HAIRS REMAINED RED. NO EXCESS METAL WAS IDENTIFIED IN THE EM FIELD. THE POSITION OF THE SIDE EMITTER WAS BOTH CHECKED AND ADJUSTED TO A NEW POSITION BUT THAT WAS UNSUCCESSFUL. THE INSTRUMENT TRACKER WAS MOVED TO THE 70 DEGREE SUCTION AND WAS VERIFIED BUT THE SAME ISSUE WITH NO NAVIGATION AND RED CROSS HAIRS CONTINUED. ULTIMATELY, THE SURGEON MOVED ON WITH PERFORMING THE SURGERY WITHOUT NAVIGATION AFTER 10 MINUTES OF TRYING TO FIX THE PROBLEM. AFTER SPEAKING WITH THE NURSING STAFF WHO WERE IN THE OPERATING ROOM (OR) DURING THE SYSTEM ISSUE, IT WAS BELIEVED THAT THE PHYSICIAN DID NOT PROGRESS THE SOFTWARE TO THE 'NAVIGATION' SCREEN. IT WAS BELIEVED THAT THE SURGEON ATTEMPTED TO NAVIGATE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470199 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001284. One submission often covers many models, so check the product and lot details in each record.

• Z-2317-2016 · Jul 18, 2016 · Terminated
  Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation Syste
• Z-2319-2016 · Jul 18, 2016 · Terminated
  MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation Sys
• Z-1601-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733608 SKULL MOUNT
• Z-1588-2014 · Apr 24, 2014 · Terminated
  MOUSE 9732721 STERILE O-ARM 10PK
• Z-1596-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801075 5/TRAY 12PK
• Z-1594-2014 · Apr 24, 2014 · Terminated
  SHUNT KIT 9733605 NON-INVASIVE
• Z-1581-2014 · Apr 24, 2014 · Terminated
  DISP 9730950 STRL SPHERE, 1 PK INSERT
• Z-1589-2014 · Apr 24, 2014 · Terminated
  PACK 9731975 TUMOR RESECTION AXIEM CR
• Z-1585-2014 · Apr 24, 2014 · Terminated
  INST 9731132 KIT CR REF FRAME DRIVER 5PK
• Z-1579-2014 · Apr 24, 2014 · Terminated
  BIOPSY NEEDLE KIT, 9733068, PASSIVE
• Z-1586-2014 · Apr 24, 2014 · Terminated
  INSTRUMENT TRACKER 9733533XOM ENT 1PK
• Z-1600-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733607 NON-INVASIVE
• Z-1583-2014 · Apr 24, 2014 · Terminated
  DRAPE 9732722 TUBE STERILE O-ARM 20PK
• Z-1592-2014 · Apr 24, 2014 · Terminated
  PIN, 9733235, 100MM, STERILE, PERC REF
• Z-1595-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801071 1/TRAY 12PK

…and 13 more.