BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 20317071 · Received September 26, 2024

    Report

    Report Number
    1723170-2024-02860
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 11, 2024
    Report Date
    October 22, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000359881
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    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: 9735821R, UBD: UNKNOWN, UDI#: UNKNOWN PRODUCT ID: 9735767, UBD: UNKNOWN, UDI#: UNKNOWN PRODUCT ID: 9735798, UBD: UNKNOWN, UDI#: UNKNOWN H3 AND H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, D15 ARE APPLICABLE. A05 IS FOR NO LIGHT ON THE POE AND NO LED ON THE CAMERA A1102 IS FOR LOCALIZER WAS NOT CONNECTED IN THE APPLICATION 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.

    Additional Manufacturer Narrative · 0

    H3: THE CABLE (PRODUCT: CABLE 9735767 POE INJTR PWR 12VDC S8 SVC, SERIAL/LOT: (B)(6)) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND NO FAILURE. THE POWER OVER ETHERNET (POE) (PRODUCT: POE REFURB 9735798R INJECTOR S8 SVC, SERIAL/LOT: (B)(6)) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND NO FAILURE. H6: CODES D02, B01, C02 APPLY TO THE SYSTEM (SURGN CART 9735665 STEALTH S8 PREMIUM, SERIAL/LOT: (B)(6)) AND THE CAMERA (CAMERA REFURB 9735821R VEGA BASE S8 SVC, SERIAL/LOT: UNKNOWN). CODES D14, B01, C19 APPLY TO THE CABLE (PRODUCT: CABLE 9735767 POE INJTR PWR 12VDC S8 SVC, SERIAL/LOT: (B)(6)) AND TO THE POWER OVER ETHERNET (POE) (PRODUCT: POE REFURB 9735798R INJECTOR S8 SVC, SERIAL/LOT: (B)(6)). 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.

    Additional Manufacturer Narrative · 0

    H3 <(>&<)> H6) A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SYSTEM UNDERWENT A COMPREHENSIVE EVALUATION, INCLUDING HARDWARE, SOFTWARE, INSTRUMENTS, VISUAL INSPECTION, AND A SELF-TEST. THE REPRESENTATIVE REPLACED THE POWER OVER ETHERNET (POE) AND THE POE POWER CABLE TO RESOLVE THE ISSUE. AFTER THE SYSTEM CHECKOUT WAS PERFORMED, THE SYSTEM WAS RETURNED TO SERVICE AND CONFIRMED TO BE PERFORMING AS INTENDED. CODES B01, C02, D02 APPLY. 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 ABOUT A NAVIGATION SYSTEM ISSUE IDENTIFIED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE LOCALIZER WAS NOT CONNECTED IN THE APPLICATION. TROUBLESHOOTING STEPS FOUND NO LIGHT ON THE POWER OVER ETHERNET (POE). THEY TRIED RESEATING V4 ON THE UNINTERRUPTIBLE POWER SUPPLY (UPS) AND POE SIDE, BUT INITIALLY, THERE WAS NO LIGHT ON THE POE AND NO LED ON THE CAMERA. THE SELF-TEST SCREENS WERE EVALUATED, AND THE FIRMWARE TO THE POE WAS NOT CONNECTED. SUDDENLY, THE POE RECEIVED COMMUNICATION AND POWER, RESTORING FUNCTIONALITY. AFTER MULTIPLE REBOOTS AND MOVING CABLES AROUND, INCLUDING MOVING THE CAMERA ARM TO EXTREME POSITIONS TO CHECK FOR ANY CABLE KINKS, THE ISSUE COULD NOT BE REPLICATED AFTER THE POE LIGHT WAS RESTORED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    SEE H11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738271 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00763000359881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11....".