FUSION Compact ™ 9735602Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00643169672956), received between Nov 18, 2016 and Jan 8, 2026 — classified as 2 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (12 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026No Device Output; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO REGISTER A PATIENT. THE SURGEON WAS UNABLE TO ACCURATELY REGISTER THE PATIENT. THE IMAGE BEING USED WAS ONLY 94 SLICES. THE SURGEON ATTEMPTED MULTIPLE REGISTRATIONS, BUT EACH ONE WAS FOUND TO BE INACCURATE ONCE IN THE VERIFY REGISTRATION. THIS ISSUE CAUSED AN UNKNOWN SURGICAL DELAY. THE IMPACT ON THE PATIENT'S OUTCOME WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003906 ↗
• MalfunctionNov 26, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SCREEN WAS BLACK. THERE WAS NO PATIENT INVOLVEMENT. TROUBLESHOOTING WAS PERFORMED. IT WAS CONFIRMED THE CD/DVD DRIVE OPENED, AND GREEN LIGHT WAS ON THE COMPACT. THE GREEN LIGHT ON THE POWER CORD BRICK WAS ON. THE SITE MOVED POWER OUTLETS WITH NO RESOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658951 ↗
• MalfunctionJul 2, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO LOAD AN EXAM VIA DISC. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383519 ↗
• MalfunctionSep 25, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO RECOGNIZE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807597 ↗
• MalfunctionJun 22, 2022Connection Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT OCCASIONALLY, THE EMITTER DID NOT LIKE TO CONNECT AND TOOK SOME TROUBLESHOOTING TO GET IT TO WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14771892 ↗
• MalfunctionSep 17, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ELECTROMAGNETIC LOCALIZATION SYSTEM COULD NOT CONNECT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487271 ↗
• MalfunctionJul 21, 2021Environmental Compatibility Problem; Application Program Freezes or Fails to Launch; Environmental Compatibility Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAD AN UNEXPECTED SHUT-DOWN, APPROXIMATELY TWENTY MINUTES AFTER BEING BOOTED UP. THE REP WAS ABLE TO REPLICATE THE ISSUE. PRIOR TO SHUTTING DOWN, SYSTEM WOULD DISPLAY, "COMMUNICATION ERROR". THERE WAS NO PATIENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SYSTEM WAS PLUGGED INTO THE WALL WHEN IT SHUT DOWN. THE CAUSE OF THE COMMUNICATION ERROR WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202583 ↗
• MalfunctionApr 22, 2021Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE USED FOR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM IS NOT ACCURATE. THERE WAS NO HARM TO THE PATIENT PRESENT, AND THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11708263 ↗
• MalfunctionFeb 8, 2021Human-Device Interface Problem; Human-Device Interface Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SITE DOES NOT USE MARK LABEL TO REGISTER. IT WAS NOTED THAT THE LAST TIME THE SITE WAS CONTACTED, THEY USED IT NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11294604 ↗
• MalfunctionFeb 8, 2021Connection Problem; Adverse Event Without Identified Device or Use Problem; Application Program Freezes or Fails to Launch; Connection Problem; Adverse Event Without Identified Device or Use Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM FOR FUNCTIONAL ENDOSCOPIC SPINAL SURGERY (FESS). IT WAS REPORTED THAT THE SOFTWARE WAS SHOWING THAT THE LOCALIZER WAS DISCONNECTED ON (B)(6) 2021 AND THE AXIEM BOX WAS NOT COMMUNICATING. THE SITE POWERED OFF THE COMPACT AND BOOTED IT WITH THE AXIEM BOX POWERED ON AND THE COMMUNICATION CABLE BETWEEN THE COMPACT AND THE AXIEM BOX, WHICH RESOLVED THE ISSUE. IT WAS NOTED THAT THE HEALTHCARE PROVIDER (HCP) AND MANUFACTURER REPRESENTATIVE WERE SETTING UP FOR A CASE WITH THE PATIENT IN THE ROOM AND THERE WAS ABOUT A 15 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11294540 ↗
• MalfunctionDec 27, 2019Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED NO FURTHER ACTIONS WERE TAKEN. THE SYSTEM WAS NO LONGER UNDER A SERVICE AGREEMENT AND WOULD BE RETURNED.

  Patient problems: No Patient Involvement

  MAUDE report 9527269 ↗
• MalfunctionJul 23, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE AXIEM BOX WAS NOT COMMUNICATING WITH THE NAVIGATION SYSTEM. THE AXIEM BOX HAD AN 8 ON THE BACK. THERE WAS SIGNAL THAT THERE WAS NO COMMUNICATION. THE EMITTER DETAILS ALSO STATES NO COMMUNICATION AND PROMPTS TO REBOOT THE SYSTEM. THE AXIEM AND THE NAVIGATION SYSTEM WERE REBOOTED WHILE CHANGING THE CONNECTION ORDER AND WHICH USB PORT THE AXIEM BOX WAS CONNECTED TO BUT THE ISSUE DID NOT RESOLVE. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT. THE REPRESENTATIVE NOTED THAT THERE IS LIKELY A SHORT IN THE CABLE CONNECTING THE AXIEM. IT WORKED WHEN THE REPRESENTATIVE TURNING ON THE SYSTEM, HOWEVER THE SITE STATES AT TIMES WHEN THEY MOVE THE TRIPOD IT WILL LOSE CONNECTION.

  Patient problems: No Patient Involvement

  MAUDE report 8815706 ↗
• MalfunctionJun 18, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM WAS NOT RECOGNIZING THE AXIEM BOX. SITE CHECKED THE CONNECTIONS AND REBOOTED THE SYSTEM. DISCONNECTED AXIEM FROM THE MONITOR AND POWERED DOWN. THEN THE NAVIGATION SYSTEM WAS RESTARTED AND THE AXIEM WAS THEN PLUGGED BACK INTO MONITOR WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS A DELAY OF LESS THAN 1 HOUR. NO KNOWN IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8708974 ↗
• MalfunctionMay 28, 2019Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE SOFTWARE WAS IN THE REGISTRATION SCREEN THE WHOLE SCREEN WAS FLICKERING BLACK. THIS ISSUE WAS OBSERVED WHEN A MEDTRONIC REPRESENTATIVE (REP) WAS TROUBLESHOOTING ON THE NAVIGATION SYSTEM. WHEN THE REP TRIED TO ROTATE THE MODEL, THE SCREEN WOULD GO BLACK UNTIL THE REP LET OFF THE SCREEN. IT WAS ALSO STATED THAT IN THE NAVIGATION TASK, IF THE SYSTEM WAS LEFT IN THAT TASK TOO LONG THE WHOLE SCREEN WOULD TURN BLACK, BUT THE SYSTEM WOULD REMAIN POWERED ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8646715 ↗
• InjuryMay 20, 2019Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT AFTER A FESS PROCEDURE, THE ANESTHESIOLOGIST IN THE ROOM NOTICED THAT THERE WAS SWELLING AROUND THE PATIENT'S LEFT EYE. THE SURGEON CAME BACK INTO THE ROOM AND USED NAVIGATION WITH AN ENDOSCOPE TO CONFIRM THAT THE PATIENT HAD AN ORBITAL HEMATOMA. THE ENT BLADE WAS USED DURING THE PROCEDURE WITH THE MICRODEBRIDER, BUT THE SURGEON STATED THE BACKSIDE OF THE INSTRUMENT WAS FACING ANTERIOR WHILE NAVIGATING (THE BLADE WAS LATERAL WITH THE CUTTING SIDE FACING AWAY FROM THE ORBIT), THEREFORE IT CANNOT BE CONFIRMED WHAT EXACTLY OCCURRED TO CAUSE THE HEMATOMA. THE SURGEON DID FURTHER DISSECTION AND INSERTED A DRAIN. AFTER THE DRAIN WAS PLACED, THE SWELLING IMMEDIATELY STARTED GOING DOWN. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR.

  Patient problems: Hematoma

  MAUDE report 8624771 ↗
• MalfunctionMay 20, 2019Human-Device Interface Problem; Output Problem; Human-Device Interface Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT DURING A CASE, THE USER WAS HAVING TRACKING ISSUES. IT WAS REPORTED THAT THEY REBOOTED THE SYSTEM TWO TIMES. THE REPRESENTATIVE (REP) STATED THAT THE FIRST REBOOT DID NOT RESOLVE THE ISSUE, BUT HE BELIEVE THE SECOND DID. THE SITE EXPERIENCED LESS THAN 1-HOUR DELAY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8624151 ↗
• MalfunctionMay 13, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THE PATIENT TRACKERS FAILED TO PERFORM AS IF THEY WERE NOT CONNECTED TO POWER. THE SITE INDICATED "LOCALIZER NOT CONNECTED." THE SITE REPORTEDLY TRIED RE-PLUGGING THE DEVICES IN. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED A 30-MINUTE SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THE SYSTEM WAS USED IN A CASE LATER THAT DAY WITHOUT ISSUE. AFTER TECHNICAL SERVICES (TS) SPOKE WITH THE SITE, IT WAS DETERMINED THE MONITOR AND AXIEM BOX WERE NOT TURNED ON IN THE CORRECT ORDER AS THE EMITTER SHOWED RED IN THE SET-UP EQUIPMENT SCREEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8604800 ↗
• MalfunctionMar 18, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SITE WAS UNABLE TO GET PASSING REGISTRATION ON THE SYSTEM. REGISTRATION WAS ATTEMPTED NUMEROUS TIMES, BUT THE POINTS LOOKED TO BE COLLECTING UNDER THE SKIN. THRESHOLDING THE MODEL DID NOT HELP AND THE HEALTH CARE PROFESSION DECIDED TO ABORT THE USE OF NAVIGATION. THERE WAS LESS THAN AN HOUR DELAY IN THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED: THE REPRESENTATIVE WAS ON THE SITE FOR A CLINICAL CASE. THERE WAS NO ISSUE DURING THE CLINICAL CASE. THE SITE USED THE SCANNER THEY USED FOR THE FIRST CASE FOR THE SECOND CASE. THE REP NOTICED THAT THE DEFAULT IMPORT THRESHOLD WAS 388, ALTHOUGH THE 3D MODEL LOOKED GOOD, THE MODEL BUILDING VIEW SHOWED THAT THERE WAS SLIGHT "FUZZINESS" AT THE EDGES OF THE 2D EXAMS THAT WERE INCLUDED IN THE MODEL. WHEN THE REPRESENTATIVE ADJUSTED THE THRESHOLD TO 720, THE 3D MODEL STILL LOOKED GREAT, BUT THE FUZZINESS AT THE EDGES OF THE 2D VIEW WERE NOT INCLUDED. THE SURGEON USED THIS FOR THE CLINICAL AND GOT A PASSING REGISTRATION ON THE FIRST TRY, AT THE END OF THE CASE THE REP A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428643 ↗
• MalfunctionMar 13, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THE SITE HAS HAD ONGOING INTERMITTENT ISSUE WITH AXIEM COMMUNICATION ERRORS. IT WAS NOTED THE SITE WILL BOOT UP THE SAME WAS EVERY TIME, AND SOMETIMES THE SYSTEM CONNECTS PROPERLY AND CAN COMMUNICATE, AND OTHER TIMES THE SITE NEEDS TO POWER CYCLE THE AXIEM BOX AND COMPUTER A FEW TIMES UNTIL THE CONNECTION IS ESTABLISHED. THIS ISSUE OCCURS PRIOR TO CLINICAL CASES AND HAS NOT INVOLVED ANY PATIENTS. A MANUFACTURER REPRESENTATIVE REPLACED THE SYSTEM COMPUTER, AND THE SYSTEM FUNCTIONED. LATER, THE SITE HAD THE ISSUE REOCCUR PRIOR TO A CLINICAL CASE. THE MANUFACTURER REPRESENTATIVE SWAPPED THE AXIEM COMMUNICATION CABLE, AND THE SYSTEM FUNCTIONED AS EXPECTED. THE MANUFACTURER REPRESENTATIVE WILL CONTACT TECHNICAL SERVICES (TS) IF ISSUE REOCCURS.

  Patient problems: No Patient Involvement

  MAUDE report 8416815 ↗
• MalfunctionFeb 19, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT, DURING A CASE, THE EMITTER HAS AN ORANGE DOTTED LINE. THE NURSE CHECKED THE AXIEM BOX AND HAS A RED 7. THE SITE TRIED USING OTHER USB PORTS BUT NO CHANGES. THE SITE HAD TO ABORT NAVIGATION. 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 8350852 ↗
• MalfunctionJan 31, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT WHILE LOADING EXAMS AND AFTER LOADING ONE EXAM, ON THE SECOND EXAM, THE SITE RECEIVED A WARNING THAT THE SYSTEM MEMORY WAS AT 98% CAPACITY AND THERE WAS ONLY 1GB LEFT OF SPACE. THE SITE TURNED OFF THE SYSTEM IN ORDER TO WORK ON IT AND DELETE SOME EXAMS. UPON STARTING THE SYSTEM, IT WOULD NO LONGER BOOT UP TO THE APPLICATION, DESPITE SEVERAL ATTEMPTS, IT WOULD NOT GET PAST THE INITIAL PRE-BOOT SEQUENCE MESSAGES. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8293649 ↗
• MalfunctionJan 24, 2019Mechanical Problem; Human-Device Interface Problem; Output Problem; Mechanical Problem; Human-Device Interface Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT HE MANUFACTURER REPRESENTATIVE (REP) WAS UNABLE TO ESTABLISH COMMUNICATION WITH THE SYSTEM. THE NAVIGATION LIGHT ON THE AXIEM BOX WOULD NOT ILLUMINATE. THE REP RESTARTED THE SYSTEM MULTIPLE TIMES WITH THE SYSTEMS SEPARATED AND WAS ABLE TO GET NORMAL BEHAVIOR ONLY A COUPLE TIMES. EMINTERFACE WOULD SOMETIMES BE AVAILABLE AND SOMETIMES WOULD NOT BE. THE EMITTER WOULD ALSO RANDOMLY STOP COMMUNICATING IF THE REP WAS ABLE TO GET THE AXIEM BOX TO BEGIN COMMUNICATING. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8275287 ↗
• InjuryJan 15, 2019Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) HAD A REGISTRATION THAT THEY WERE SATISFIED WITH, ON THE ANTERIOR ASPECT OF THE PATIENT. AS THE HCP GOT TO THE SPHENOID THEY USED AN OSTIEM SEEKER AND CAUSED A CEREBROSPINAL FLUID (CSF) LEAK. THE HCP CONSULTED WITH OTHER HCP AND STOPPED THE CSF LEAK. THE HCP PROCEEDED WITH THE PROCEDURE. THERE WAS LESS THAN AN HOUR DELAY IN THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: Cerebrospinal Fluid Leakage; No Known Impact Or Consequence To Patient

  MAUDE report 8249898 ↗
• MalfunctionDec 18, 2018Computer Software Problem; Computer Software Problem

  ON (B)(6) 2018, (B)(6) (REP, HCP); MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), IT WAS NOTED THAT THE ELECTROMAGNETIC FIELD WAS REDUCED IN SIZE FOR NAVIGATION. THE SURGEON NOTED THERE WAS NOT SUBSTANTIAL METAL INTERFERENCE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8174046 ↗
• MalfunctionNov 16, 2018Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE EXAMS WOULD NOT LOAD AFTER SELECTING THE CORRECT UNSTRUCTURED OPTION. AFTER REBOOTING SEVERAL TIMES THE EXAMS LOADED. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8078301 ↗