BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO COAGULATION INSTRUMENT, BIPOLAR, ANGLED, 21C

    MDR report key: 1841221 · Received September 20, 2010

    Report

    Report Number
    8010177-2010-00325
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 23, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    GEI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    THERE WAS NO DAMAGE ON THE PRODUCT WHEN IT WAS OPENED. HOWEVER, DURING THE USE OF MICRO COAGULATION INSTRUMENT TIP (ANGLED) AT THE OPERATING ROOM, THE INSTRUMENT DIDN'T OPERATE TO GRASP. THE LINKAGE PART OF TIP FINALLY WAS FOUND TO COME OFF THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO COAGULATION INSTRUMENT, BIPOLAR, ANGLED, 21C INSTRUMENT GEI STRYKER OSTEOSYNTHESIS FREIBURG NA AA02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK