StealthStation S8 Platform 9735669 (UDI 00763000360450)Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00763000360450), received between Mar 5, 2021 and Sep 30, 2026 — classified as 71 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (26 reports).

2 other recalls cover devices cleared under the same FDA submission (K162309); 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 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Naturally Worn

  Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that the system had wear on the main power cable to the system. The grey coating was changing to white. There were no tears and no cable showing. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948263 ↗
• MalfunctionMar 6, 2026Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED. IT WAS REPORTED THAT THE SIGNAL WAS LOST WITH THE MONITOR. SOMETIMES WHEN IT IS TURNED ON, THERE IS NO VIDEO SIGNAL ON EITHER MONITOR, DISPLAYING A COMMUNICATION FAILURE. WHEN IT IS RESET, IT TURNS ON NORMALLY AGAIN. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED PRE-OPERATIVELY WITH A PATIENT PRESENT. THERE WAS A DELAY OF ABOUT 5 MINUTES AND NO IMPACT ON PATIENT OUTCOME. CUSTOMER REPORTED ISSUE THAT THE SYSTEM WOULD NOT POWER ON, BLACK SCREEN AFTER RESTART, THEN IT WORKED. PROCEDURE INFORMATION WAS UNKNOWN. NO ISSUES WERE DETECTED AFTER CHECKING THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539484 ↗
• MalfunctionFeb 4, 2026Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE HAD ISSUES WITH THE SYSTEM "NOT DETECTING OTHER INSTRUMENTS OR INTERMITTENTLY SAYING THE INSTRUMENT CANNOT BE VERIFIED/RECOGNIZED." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260264 ↗
• MalfunctionJan 30, 2026Computer Software Problem; Use of Device Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THIS ISSUE CAUSED NO SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220764 ↗
• MalfunctionDec 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem; Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT DURING A CASE, THE SURGEON WAS EXPERIENCING ISSUES WITH NAVIGATION. THERE WAS A NAVIGATIONAL INACCURACY. WHILE TROUBLESHOOTING, TECHNICAL SERVICES (TS) VIDEO CALLED THE SITE CONTACT. THE SURGEON STATED THAT WHEN HOLDING THE INSTRUMENT IN THE FIELD OF ELECTROMAGNETIC (EM) AND VISIBLE IN THE TRACKING WINDOW, THE CROSS HAIRS WERE NOT MOVING. TS NOTED THAT THEY WERE IN THE REGISTRATION TAB AND NOT NAVIGATION. REGISTRATION ACCURACY WAS 2.8MM. ONCE THEY PROCEEDED TO NAVIGATION, THE 3D MODEL WAS FROM THE PATIENT'S UPPER LIP TO THE MIDDLE OF THE BRIDGE OF THE NOSE. TS HAD SITE GO BACK TO IMAGES TO REVIEW THE SCAN AND IMAGES WERE FLAGGED AS NOT OPTIMAL FOR STEALTH AND APPEARED TO HAVE MISSING SLICES, THEREFORE THE NAVIGATION WAS INACCURATE. SURGEON COULD ACCURATELY TOUCH THE TIP OF THE PATIENT'S NOSE AND IT WOULD APPEAR ACCURATELY IN THE SOFTWARE, BUT ONCE HE HAD AN INSTRUMENT IN THE NASAL CAVITY, HE WOULD LOSE NAVIGATION. TS NOTED THIS WAS BECAUSE THERE WAS NO MORE SLICES FOR THE ANATOMY HE WAS ENTERING, THEREFORE A SCAN ISSUE. SURGEON CONFIRMED THEY USED A 3RD PARTY IMAGIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922822 ↗
• MalfunctionDec 15, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS DISPLAYING A LOCALIZER FAULTED ERROR. TROUBLESHOOTING WAS PERFORMED. TECHNICAL SERVICES (TS) HAD THE MANUFACTURING REPRESENTATIVE (REP) PERFORM PRINT CAMERA DIAGNOSTICS FOR WHEN THE BREAK OUT BOX WAS PLUGGED AND UNPLUGGED FROM THE CONTROLLER, WHICH BOTH DISPLAYED: LOCALIZER FAULTED - RTCODE, BOB: STOPPED, CONTROLLER: FAULTED, AMPLIFIERS ENABLED: FALSE, AND TCA STOPPED. THERE WAS NO PATIENT PRESENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE BREAK OUT BOX (BOB) BROKE WHEN PLUGGING IN THE BOB FROM THE ENT SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT SOMEONE AT THE SITE UNPLUGGED THE BOB ON THE SYSTEM AND EXPOSED SOME WIRES. WHEN IT WAS INSPECTED THEY COULD NOT GET THE WIRES TO EXPOSE ON THE BOB. THE ISSUE COULD NOT BE REPLICATED. THE MESSAGE WAS RELAYED TO THE TECH SUPPORT TEAM THE TESTED THE SYSTEM USING A NEURO NAVIGATION SYSTEM. THE TECH SUPPORT PERSON INSTRUCTED TO PLUG THE BOB INTO BOTH SYSTEMS TO TEST IT OUT. WHEN THAT HAD OCCURRED THE CONTROLLER ON THE NEURO SYSTEM ALSO GOT FRIED. THE NEURO SYSTEM WAS THEN R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23805874 ↗
• MalfunctionJun 25, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO DOWNLOAD 2024 PATIENT FILES, HOWEVER, THEY CAN DOWNLOAD THE 2019 PATIENT FILES. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330070 ↗
• MalfunctionJun 16, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE BENT THE PINS ON THE FLAT EMITTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214246 ↗
• MalfunctionMay 19, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN CONTEXT IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT DURING SURGERY, THE BREAKOUT BOX WAS RIPPED OUT OF THE SYSTEM'S CONTROLLER WITH FORCE. AS A RESULT, THE BREAKOUT BOX CABLE WAS DAMAGED. IT WAS NOT CLEAR AT THE TIME OF CALL IF THE CONTROLLER WAS DAMAGED AS WELL. AS A RESULT, THE SURGERY WAS CANCELLED, AS WELL AS ALL SURGERIES FOR FORESEEABLE FUTURE. PATIENT IMPACT NOT PROVIDED AS WELL AS SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044331 ↗
• MalfunctionApr 16, 2025Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THEY WERE UNABLE TO LOAD A PATIENT DISC ONTO THE SYSTEM. WHEN TRYING TO LOAD THE EXAM, THE SYSTEM WOULD PROMPT WITH A "CANNOT INSERT SERIES INTO DATABASE" ERROR. THE SITE WAS ABLE TO LOAD OTHER DISCS WITHOUT ISSUE. THE SITE REBURNED THE INITIAL PATIENT ONTO OTHER DISCS WITH NO CHANGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21851538 ↗
• MalfunctionFeb 7, 2025Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. THE SITE REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE SURGEON WAS ABLE TO REGISTER AND NAVIGATE USING SCANS FROM A DIFFERENT PATIENT. THE SITE SWITCHED MACHINES AND REREGISTERED THE PATIENT. THERE WAS A SURGICAL DELAY OF LONGER THAN 1 HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333919 ↗
• MalfunctionFeb 7, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXAMS WERE LOADING EXTREMELY SLOWLY VIA CD. THE MOST RECENT SCAN TOOK APPROXIMATELY 1 HOUR TO LOAD.  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333296 ↗
• MalfunctionJan 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; 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 EXPER IENCED INACCURACIES AFTER REGISTERING A PATIENT. IT WAS UNKNOWN IF THERE WAS A DELAY, AND IF THERE WAS PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160076 ↗
• MalfunctionJan 9, 2025Communication or Transmission Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THERE DID NOT APPEAR TO BE AN ISSUE WITH THE NAVIGATION SYSTEM. THE MANUFACTURER REPRESENTATIVE STATED THAT THEY TRIED LOADING THE SAME SCANS ONTO ONE OF THE PREMIUM UNITS AND GOT THE SAME RESPONSE. THEY WERE THINKING IT WAS AN ISSUE WITH THE IMAGING COMPANY THAT THEY WERE USING LOCALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112547 ↗
• MalfunctionNov 26, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE EM (ELECTROMAGNETIC) INSTRUMENT INTERFACE BOX DID NOT FUNCTION. THE ISSUE WAS IDENTIFIED WHEN AN ATTEMPT WAS MADE TO CONNECT THE BOX, WHICH FAILED TO OPERATE, WHILE ANOTHER EM INSTRUMENT INTERFACE BOX FROM THE SAME ACCOUNT WORKED IMMEDIATELY WHEN CONNECTED TO THE SYSTEM. THERE WAS NO VISIBLE PHYSICAL DAMAGE OBSERVED ON THE NON-FUNCTIONING UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784003 ↗
• MalfunctionNov 26, 2024Application Program Problem; Device Sensing Problem; Application Program Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS DISPLAYING A "LOCALIZER NOT CONNECTED" ERROR MESSAGE. TROUBLESHOOTING STEPS WERE PERFORMED. THE SITE WAS TO ATTEMPT A RECONNECT AND REBOOT OF THE SYSTEM, BUT IT IS UNKNOWN IF IT RESOLVED THE ISSUE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783033 ↗
• MalfunctionOct 25, 2024Mechanical Problem; Connection Problem; Mechanical Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE EMITTER BOX AND ELECTROMAGNETIC WERE NOT CONNECTED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL TROUBLESHOOTING WAS PERFORMED. A REPRESENTATIVE INSPECTED THE DEVICE. THEY RESET CONNECTION OF AXIM CONTROLLER THEN FOUND AXIEM CONTROLLER & AXIEM BOX FAULTY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535232 ↗
• MalfunctionOct 21, 2024Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THERE WAS DIFFICULTY WITH REGISTERING THE PATIENT. THE SITE NOTED THAT AFTER COMPLETING A TRACE REGISTRATION, THE TRACE WOULD JUMP OVER TO THE PATIENT'S RIGHT. TROUBLESHOOTING WAS PERFORMED. TECHNICAL SUPPORT (TS) HAD THE SITE REPOSITION THE REFERENCE FRAME CLOSER TO THE PATIENT. THE SITE WAS ABLE TO SUCCESSFULLY REGISTER AFTER MOVING THE FRAME. THE ISSUE WAS RESOLVED ON THE CALL. THE LENGTH OF THE SURGICAL DELAY IS PENDING. THE PATIENT OUTCOME IS PENDING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500075 ↗
• MalfunctionOct 14, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE EMITTER CABLING IS DAMAGED AND WIRING VISIBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446226 ↗
• MalfunctionSep 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THEY HAD SIGNIFICANT ISSUES REGISTERING THE PATIENT. REP WAS NOT ON SITE TO TROUBLESHOOT AND WAS NOTIFIED AFTER THE FACT. SITE WAS EVENTUALLY ABLE TO PASS AFTER MULTIPLE ATTEMPTS, BUT ONLY AFTER ACHIEVING RESULTS HIGHER THAN 5.0MM. THERE WAS NO PATIENT IMPACT AND A DELAY OF LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20233748 ↗
• MalfunctionSep 5, 2024Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT SITE WAS UNABLE TO RETRIEVE FROM PACS. THEY WERE ABLE TO PUSH BUT S8 IS NOT SET UP TO RECEIVE. THE CALLER CONFIRMED THAT AE TITLE, IP ADDRESS AND PORT WERE ALL SET-UP CORRECTLY ON PACS AND HAD FULL PERMISSION.  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153820 ↗
• MalfunctionJun 18, 2024Application Program Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT AT SOME POINT DURING A CASE, THE SITE EXPERIENCED AN INTERNAL ERROR MESSAGE (ERROR CODE 64). RECOMMENDED REBOOTING AND IF THAT DOES NOT RESOLVE THE ISSUE THEN TO DELETE THE PATIENT OFF THE SYSTEM AND RELOAD THE PATIENT. THERE WAS NO PATIENT IMPACT REPORTED. 2024-FEB-21 INTERFACE UPDATE (REP): ADDITIONAL INFORMATION WAS RECEIVED. THE TYPE OF PROCEDURE WAS A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE ISSUE OCCURRED INTRA-OPERATIVELY. THERE WAS LESS THAN AN HOUR DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19560910 ↗
• MalfunctionJun 17, 2024Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE 3D MODEL RENDERING WOULD NOT DISPLAY AFTER ERROR 64. THE MEDTRONIC REPRESENTATIVE (REP) BELIEVED THAT THIS HAPPENED AFTER THE ERROR 64 MESSAGES. REBOOTED THE SYSTEM AND THE ISSUE WAS RESOLVED. THERE WAS LESS THAN AN HOUR DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19555077 ↗
• MalfunctionMar 19, 2024Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO PULL FROM ELECTRONIC PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS). IT WAS PREVIOUSLY SET-UP AND WORKING FINE. NO KNOWN CHANGES. SELF-TEST DISPLAYED, "NO IP ADDRESS DETECTED, NO MAC ADDRESS DETECTED," FOR BOTH WIRED AND WIRELESS. THE INTERNAL NETWORK TAB ONLY DISPLAYED GREEN ONLY FOR THE SURGEON COMPUTER AND THE UNINTERRUPTIBLE POWER SUPPLY (UPS), EVERYTHING ELSE DISPLAYED AS UNAVAILABLE. CART CONFIGURATION CORRECTLY SET FOR EAR, NOSE & THROAT (ENT). NETWORK CONFIGURATION WAS BLANK, WHEN POPULATING NO CHANGE. THE MEDTRONIC REPRESENTATIVE (REP) WAS UNABLE TO REMOVE PANELS TO VERIFY STATUS OF ROUTER OR UPS. THERE WAS NO PATIENT INVOLVEMENT. (B)(6) 2024 IUD (OTHER): ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE MANUFACTURER REPRESENTATIVE (REP) WAS ABLE TO REMOVE THE BACK PANEL AND THE CONFIRMED THE COMPUTER WAS IN 'REFRESH' AND ALL CONNECTIONS TO THE ROUTER WERE PROPERLY SEATED WITH NO DAMAGE. CONNECTION WAS VERIFIED IN THE RIGHT PORTS OF THE ROUTER IN THE COMPUTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932566 ↗
• MalfunctionNov 6, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE FIELD OF VIEW OF THE SIDE EMITTER HAD SIGNIFICANTLY REDUCED. THE FIELD REPRESENTATIVE (REP) HAD TO BE 3 INCHES AWAY FROM THE SIDE EMITTER FOR THE INSTRUMENT TO BE PICKED UP BY THE EMITTER. THE SITE WAS USING THE ELECTROMAGNETIC EAR NOSE AND THROAT HEAD FRAME TO REGISTER PATIENTS AND THE EMITTER HAD TO BE ALMOST TOUCHING THE PRONG ON THE HEAD FRAME IN ORDER FOR THE INSTRUMENT TO BE PICKED UP AS WELL. THE FIELD OF VIEW ON THE SIDE EMITTER WAS REDUCED AND THERE WAS TROUBLE VERIFYING AND NAVIGATING INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. TROUBLESHOOTING WAS PERFORMED, THE REP TESTED THE SIDE EMITTER NOT IN RANGE OF THE SYSTEM SO THAT THE SYSTEM WOULD NOT INTERRUPT THE SIDE EMITTER. THE SYSTEM REPEATED THE BEHAVIOR. THE STINGRAY TRACKER WAS NOT AVAILABLE FROM THE SITE OR THE REP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074554 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162309. One submission often covers many models, so check the product and lot details in each record.

• Z-1776-2024 · Mar 26, 2024 · Open, Classified
  Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutane
• Z-1995-2020 · Aug 9, 2019 · Terminated
  Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS Licen