BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 1181919 · Received September 26, 2008

    Report

    Report Number
    1219930-2008-00699
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE WHITE TIP BROKE AND FELL INTO THE PATIENT BUT WAS REMOVED WITHOUT HARM TO PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT ENERGY LFL NORTH HAVEN - USS N4K474

    Patients

    Seq Age Sex Outcome Treatment
    1