BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 ASEPTIC HOUSING ASSY

    MDR report key: 2241603 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03242
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 11, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE MFR FOR INVESTIGATION. 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 ASEPTIC BATTERY HOUSING OPENED DURING A PROCEDURE, EXPOSING THE NON-STERILE BATTERY. THERE WAS NO ALLEGATIONS OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 ASEPTIC HOUSING ASSY KIJ STRYKER INSTRUMENTS KALAMAZOO 09175

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK