BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX HOOK PROBE LONG

    MDR report key: 1062689 · Received June 18, 2008

    Report

    Report Number
    1219930-2008-00465
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    February 13, 2008
    Report Date
    May 26, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    LFL
    PMA / PMN Number
    K971861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAP CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: A SMALL WHITE PLASTIC RING FELL OFF THE DEVICE TIP. IT BROKE INTO TWO PIECES AND FELL INTO THE PT CAVITY. THE PIECES WERE REMOVED FROM THE PT ABDOMEN. ANOTHER SHEARS WAS USED TO FINISH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX HOOK PROBE LONG ENERGY DEVICE LFL NORTH HAVEN - USS N7L203

    Patients

    Seq Age Sex Outcome Treatment
    1