BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 1250826 · Received November 25, 2008

    Report

    Report Number
    1219930-2008-00854
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    November 17, 2008
    Report Date
    November 19, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE RPTR: THE TIP OF THE DEVICE BROKE AND WAS REMOVED FROM PT CAVITY. THERE WAS NO OBSTRUCTION DURING USE OF THE DEVICE. PT HAS A HISTORY OF CARCINOMA BUT NO INJURY WAS REPORTED. THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT ENERGY DEVICE LFL NORTH HAVEN - USS N8F244

    Patients

    Seq Age Sex Outcome Treatment
    1