BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 22361250 · Received June 30, 2025

    Report

    Report Number
    1723170-2025-02548
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    August 29, 2024
    Report Date
    June 30, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000272746
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735818; PRODUCT ID: 9735764R, SERIAL/LOT #: (B)(6), UDI#: (B)(4); PRODUCT ID: 9735992, SERIAL/LOT #: (B)(6); PRODUCT ID: 9736356 ; PRODUCT ID: 9735820, SERIAL/LOT #: (B)(6): H3: A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE COMPUTERS, SOLID-STATE DRIVE (SSD), SYSTEM CONTROL UNIT (SCU), ROUTER, AND DIGITAL MICROSCOPE CABLES WERE REPLACED. THE MEDTRONIC REPRESENTATIVE (REP) BYPASSED BASICALLY EVERY POSSIBLE C ONNECTION. THEY TESTED WITH DIFFERENT PARTS FROM WORKING SYSTEMS. THEY EVENTUALLY BROUGHT A DEMO SYSTEM THAT WAS INSTALLED, TESTED, CONFIGURED AND BROUGHT UP TO THE NETWORK WITH SAME SETTINGS AS BEFORE. CODES FDM B01, FDR C02, FDC D02 ARE APPLICABLE TO THIS ANALYSIS. D9, H2, H3: THE HARDWARE (9735820, LOT NO. T902335) WAS RETURNED AND ANALYSIS WAS PERFORMED. THE RETURNED SCU WAS FOUND TO BE FULLY FUNCTIONAL WHEN CONNECTED TO A KNOWN GOOD SYSTEM. THE SCU HAD NORMAL TRACKING FOR ALL THREE PORTS. NO PROBLEM WAS FOUND. CODES FDM B01, FDR C19, FDC D14 ARE APPLICABLE TO THIS ANALYSIS. THE HARDWARE (9735764, LOT NO. 2314F02126) WAS RETURNED AND ANALYSIS WAS PERFORMED. THE COMPUTER POWERED ON WHEN POWER WAS APPLIED. AFTER MULTIPLE POWER CYCLES, NO BOOT UP OR VIDEO ISSUES WERE OBSERVED. THE NETWORK AND TERADICI CONFIGURATIONS WERE SET CORRECTLY. THE VIDEO CAPTURE CARD FUNCTIONED CORRECTLY. ALL DISPLAY PORTS-DVI, HDMI AND DP FUNCTIONED CORRECTLY. THE SOUND FUNCTIONED ON THE HDMI AND DP PORTS. THE COMPUTER PASSED ALL BURN-IN TESTING V 9.1. THE COMPUTER WAS FULLY FUNCTIONAL. CODES FDM B01, FDR C19, FDC D14 ARE APPLICABLE TO THIS ANALYSIS. THE HARDWARE (9735992, LOT NO. 1708334591500726) WAS RETURNED AND ANALYSIS WAS PERFORMED. THE LEGACY CHECKPOINT WAS TESTED AND THE WAN, DMZ, AND ALL EIGHT ETHERNET PORTS WERE FOUND TO BE FUNCTIONING PROPERLY, IT DID NOT PASS THE CONFIGURATION VALIDATION. THE DEVICE WAS SUBSEQUENTLY FACTORY RESET AND RECONFIGURED, AFTER WHICH IT SUCCESSFULLY PASSED ALL VALIDATION CHECKS. CODES FDM B01, FDR C10, FDC D02 ARE APPLICABLE TO THIS ANALYSIS. H6: MULTIPLE ANNEX G CODES WERE REPORTED. G0200702 CORRESPONDS TO CONCOMITANT PRODUCT 9736356 THAT COMPRISES THE REPORTED EVENT. G05001 CORRESPONDS TO CONCOMITANT PRODUCT 9735820 THAT COMPRISES THE REPORTED EVENT. G02007 CORRESPONDS TO CONCOMITANT PRODUCT 9735764R THAT COMPRISES THE REPORTED EVENT. G0200703 CORRESPONDS TO CONCOMITANT PRODUCT 9735992 THAT COMPRISES THE REPORTED EVENT. G04034 CORRESPONDS TO CONCOMITANT PRODUCT 9735818 THAT COMPRISES THE REPORTED EVENT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED PER-OPERATIVELY TO A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE SITE COULDN'T CONNECT ONE OF THEIR TWO NAVIGATION SYSTEMS TO EITHER OF THEIR MICROSCOPES. THE MANUFACTURER REPRESENTATIVE (REP) WENT ON SITE TO TROUBLESHOOT THROUGH THE FOLLOWING STEPS. THE SITE HAD TWO NAVIGATION SYSTEMS, AS WELL AS TWO MICROSCOPES. A COUPLE OF DAYS PRIOR, THE SITE HAD THE SECOND SYSTEM IN THE OPERATING ROOM (OR), AND IT FAILED TO CONNECT TO THE SECOND MICROSCOPE. THEY CHANGED TO THE FIRST NAVIGATION SYSTEM AND IMMEDIATELY GOT A CONNECTION. BOTH NAVIGATION SYSTEMS GOT NEW COMPUTERS DURING THE PAST YEAR, AND BOTH WERE INDICATED TO BE ON THE SAME VERSION. THE REP TRIED THE FIRST SYSTEM WITH BOTH MICROSCOPES, AND THEY WERE BOTH SUCCESSFUL. THE SECOND NAVIGATION SYSTEM WAS TRIED WITH BOTH MICROSCOPES, AND THEY BOTH FAILED. MULTIPLE RESTARTS ON BOTH UNITS IN ALL POSSIBLE ORDERS WERE PERFORMED. THE REP MADE SURE ALL OF THE SETTINGS IN THE MICROSCOPE WERE CORRECT. THE NETWORK CONNECTION WAS BYPASSED WITH AN EXTERNAL NETWORK CABLE. THE NETWORK CONNECTOR INSIDE NAVIGATION DIRECT TO SWITCH WAS ALSO BYPASSED. THE REP MADE SURE THE IP ADDRESS WAS PROPERLY SET TO STATIC ON ALL UNITS. THE CALIBRATION FILES FROM THE FIRST SYSTEM WERE COPIED AND REPLACED THE ONES IN THE SECOND SYSTEM. IT WAS FOUND THERE WAS A FAILURE WHEN THE INTEGRATION CABLE WAS PROPERLY CONNECTED, RESULTING IN AN ERROR MESSAGE ON MICROSCOPE WHEN ENABLING "NAVIGATION (EXPANDED)", SOMETHING ALONG THE LINES WITH "NO CONNECTION, CHECK XX". THE REP WAS UNABLE TO PING NAVIGATION FROM THE MICROSCOPE OR VICE VERSA. THE NAVIGATION DID NOT HAVE A CONNECTION [GREEN IP IN DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) SETTINGS]. ALSO, THERE WAS A FAILURE WHEN THE INTEGRATION CABLE WAS BYPASSED WHICH RESULTED IN "NOTHING" WHEN "NAVIGATION (EXPANDED)" WAS ENABLED. THE IP TURNED GREEN ON THE NAVIGATION SYSTEM, BUT IT WAS NOT POSSIBLE TO PING. THE EXPECTED POP UP TO ACTIVATE A CERTAIN PORT DID NOT SHOW UP, AND IT WASN'T POSSIBLE TO PING FROM EITHER END. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE BEFORE THE SURGEON OPTED TO ABORT THE USE OF NAVIGATION. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234775 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00763000272746

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female "SEE H11....".