BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 20207027 · Received September 12, 2024

    Report

    Report Number
    1723170-2024-02664
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 12, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000359881
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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: 9735843, SERIAL/LOT#: UNKNOWN, PRODUCT ID: 9735798, SERIAL/LOT#: (B)(6), PRODUCT ID: 9735821R, SERIAL/LOT#: (B)(6), UDI#: (B)(4). H3: A MEDTRONIC REPRESENTATIVE, WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED, THAT THE POWER OVER ETHERNET (POE) INJECTOR LED WAS RED. THE MANUFACTURER REPRESENTATIVE (REP), ENSURED EVERYTHING WAS SEATED PROPERLY BOTH IN THE POE INJECTOR AND BACK OF THE CAMERA. AFTER PLUGGING ANOTHER ETHERNET CABLE INTO THE POE DIRECTLY INTO THE BACK OF THE CAMERA, THE POE LED WAS STILL RED. THE POE INJECTOR WAS REPLACED, BUT IT HAD NO EFFECT, AS THE LIGHT STILL REMAINED RED. THE "LOCALIZER NOT CONNECTED" ERROR REMAINED AND THE CAMERA HAD NO INDICATOR LIGHTS ON. IT WAS CONFIRMED, THAT THE CAMERA CART MONITOR WAS FUNCTIONING NORMALLY. THE REP CHECKED THE ETHERNET CONNECTION TO THE BACK OF THE CAMERA ARM AND THE REP RESEATED THE CONNECTIONS ON BOTH ENDS OF THE CONNECTOR NOTING, NO OBVIOUS DAMAGE. THE ETHERNET CONNECTION WAS RESEATED TO THE BACK OF THE CAMERA WITH NO EFFECT. THE REP SWAPPED THE POE ETHERNET CONNECTIONS BETWEEN THE CARTS. THE REP PLUGGED THE POE ETHERNET INTO A KNOWN-FUNCTIONING CAMERA CART POE. THE POE LIGHT TURNED RED AND THE CAM ERA DID NOT DISPLAY ANY LIGHTS. THE REP THEN PLUGGED THE POE ETHERNET FROM A KNOWN-FUNCTIONING CAMERA CART INTO THE ORIGINAL POE. THE POE LIGHT TURNED GREEN AND THE CAMERA DISPLAYED A GREEN LIGHT. ADDITIONALLY, THE "LOCALIZER NOT CONNECTED" ERROR DISAPPEARED. SWAPPING THE CAMERA ARM CABLE CHAIN DID NOT RESOLVE THE ISSUE. THE CAMERA WAS THEN REPLACED, WHICH RESOLVED THE REPORTED EVENT. THE NAVIGATION SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE POE INJECTOR (9735798) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE POE INJECTOR WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE CAMERA ETHERNET CABLE (9735843) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE CAMERA ETHERNET CABLE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE CAMERA (9735821R) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND, THAT THE RETURNED POSITIONING SENSOR UNIT (PSU) HAD MANY NICKS AND SCRATCHES ON THE HOUSING AND LENSES. THE PSU WOULD NOT POWER UP ON THE TEST BENCH. ANALYSIS FOUND, THAT THE REPORTED EVENT WAS RELATED TO AN ELECTRICAL ISSUE. H6: FDM B01, FDR C02, FDC D02 ARE APPLICABLE TO THE SYSTEM CHECKOUT. FDM B01, FDR C19 AND FDC D14 ARE APPLICABLE TO THE HARDWARE ANALYSIS OF PRODUCT 9735798 AND 9735843. FDM B01, FDR C02 AND FDC D02 ARE APPLICABLE TO THE HARDWARE ANALYSIS OF PRODUCT 9735821R. MULTIPLE ANNEX G CODES WERE REPORTED. G05001 CORRESPONDS TO THE CONCOMITANT PRODUCT 9735821R, G02021 CORRESPONDS TO THE CONCOMITANT PRODUCT 9735798, G02004 CORRESPONDS TO THE CONCOMITANT PRODUCT 9735843. 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED, THAT THE CAMERA DID NOT RECEIVE POWER WHEN THE CAMERA CART WAS TURNED ON. NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592353 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00763000359881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown