BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    MDR report key: 954905 · Received November 27, 2007

    Report

    Report Number
    1219930-2007-00735
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    November 9, 2007
    Report Date
    November 12, 2007
    Manufacturer
    NORTH HAVEN-USS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: NOV 16, 2007.

    Description of Event or Problem · 1

    PROCEDURE: LAP NEPHRECTOMY. ACCORDING TO THE REPORTER: THE TISSUE PAD WAS GETTING DISTORTED AND WHITE PLASTIC TIP WAS COMING OFF DURING SURGERY. ANOTHER SHEARS WAS USED FOR THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT ENERGY DEVICE LFL NORTH HAVEN-USS N7E62

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR