BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAIN CART 9735665 STEALTH S8 PREMIUM

    MDR report key: 7939160 · Received October 5, 2018

    Report

    Report Number
    1723170-2018-05007
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    September 6, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE POWER OVER ETHERNET (POE) INJECTOR LIGHT WAS ILLUMINATED RED WITHIN THE CAMERA CART. THE CABLES OF THE POE INJECTOR WERE RESEATED WITH NO CHANGE. AN ATTEMPT TO BYPASS THE POE INJECTOR WAS MADE WITH NO CHANGE. THE POE INJECTOR AND CAMERA CHAIN ETHERNET COMPONENTS WERE REPLACED AND OPTICAL COMMUNICATION WAS RESTORED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE CAMERA ETHERNET CABLES WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND NO FAULT WITH THE CABLES. THE CABLE WERE CONTINUITY TESTED FOR OPENS AND SHORTS, AND ALL TESTING PASSED. THE POE INJECTOR WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THE POE WAS TESTED AND INITIALLY POWERED THE CAMERA FOR OVER THREE HOURS, AND AFTER RUNNING OVERNIGHT, THE POE INJECTOR LED TURNED RED. THE POE WAS POWER CYCLED AND THE LED REMAINED RED AND THERE WAS NO OUTPUT POWER. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO AN ELECTRICAL ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT I NTRA-OPERATIVELY, AFTER NAVIGATING FOR OVER AN HOUR, THE SOFTWARE SHOWED LOCALIZER NOT DETECTED. THE CAMERA HAD NO LIGHTS AND THE LASER WAS NOT WORKING. THE CAMERA CART MONITOR CONTINUED FUNCTIONING DURING THIS TIME AND THE CAMERA DID NOT LOOK DAMAGED. A MANUFACTURER REPRESENTATIVE HAD THE SITE PULL THE CAMERA CART FROM A DIFFERENT NAVIGATION SYSTEM, AND THE CASE CONTINUED. THE PROCEDURE WAS COMPLETED USING THE NAVIGATION SYSTEM AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. SURGICAL TIME WAS EXTENDED BY LESS THAN ONE HOUR DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781354 MAIN CART 9735665 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR