BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS LONG

    MDR report key: 1232077 · Received November 7, 2008

    Report

    Report Number
    1219930-2008-00811
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 5, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR INITIAL REPORT SUBMITTED: 11/7/2008.

    Description of Event or Problem · 1

    ACCORDING TO THE RPTR: THE DEVICE DID NOT COAGULATE PROPERLY AND DID NOT CUT THE TISSUE PROPERLY. THE JAWS GOT MISALIGNED AFTER ABOUT 20 APPLICATIONS. THE DEVICE DID NOT WORK ANYMORE AND WAS CHANGED. NOTHING FELL INTO THE PT CAVITY AND THE PT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS LONG ENERGY LFL NORTH HAVEN - USS N7E402

    Patients

    Seq Age Sex Outcome Treatment
    1