BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 938681 · Received October 19, 2007

    Report

    Report Number
    938681
    Event Type
    Malfunction
    Date Received
    October 19, 2007
    Date of Event
    October 4, 2007
    Report Date
    October 19, 2007
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    MOQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A FEW MONTHS AGO THE STRYKER REP FOR THE HOSPITAL TOLD THE OR STAFF THEY COULD EXTEND THE LIFE OF THEIR STRYKER ELECTRIC HANDPIECE (SYSTEM 4/SYSTEM 5) BATTERY PACKS/BATTERIES BY FLASH STERILIZING THEM INSTEAD OF USING THE HYDROGEN PEROXIDE STERILIZER. FOLLOWING THIS CHANGE IN PROCESS, WHEN BATTERIES WERE SENT BACK TO STRYKER FOR REPLACEMENT, STRYKER BEGAN REPORTING TO US THAT OUR BATTERY PACKS WERE FOUND TO HAVE WATER IN THEM.AS A TEST, WE FLASHED A BATTERY PACK AND THEN PLACED IT IN THE HYDROGEN PEROXIDE STERILIZER AND THE LOAD FAILED, INDICATING THERE WAS MOISTURE IN THE LOAD. WE THEN OPENED THE BATTERY PACK AND FOUND NOT ONLY MOISTURE, BUT ALSO EXTENSIVE CORROSION OF THE BATTERY. WE OPENED SEVERAL OTHER BATTERY PACKS AND ALSO FOUND EXTENSIVE CORROSION OF THE BATTERIES AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INSTRUMENTS BATTERY PACK, SURGICAL INSTRUMENT MOQ STRYKER INSTRUMENTS REF 4115 05286

    Patients

    Seq Age Sex Outcome Treatment
    1