BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY

    MDR report key: 1935463 · Received December 13, 2010

    Report

    Report Number
    1811755-2010-02005
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 19, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE MFR FOR EVAL. WHEN THE DEVICE IS RECEIVED, A QUALITY INVESTIGATION WILL BE PERFORMED AND A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WAS SMOKING. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BATTERY SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENT KIJ STRYKER INSTRUMENTS KALAMAZOO 10205

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK