BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROCARE/OPUS

    MDR report key: 1080837 · Received July 23, 2008

    Report

    Report Number
    MW5007741
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ARTHROCARE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT USED DURING SURGERY (PERFORMED PROPERLY). UPON CLEANING INSTRUMENT, IT WAS NOT WORKING PROPERLY. CONTACTED SALES REP, HE EXAMINED INSTRUMENT AND IT WAS NOTED THAT A VERY SMALL "PIN" THAT HOLDS INSTRUMENT TOGETHER WAS MISSING. X-RAY WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROCARE/OPUS UNDER PUNCH GEI ARTHROCARE OM9451 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other