BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 4251238 · Received November 4, 2014

    Report

    Report Number
    MW5039012
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 30, 2014
    Report Date
    November 4, 2014
    Manufacturer
    JOHNSON AND JOHNSON
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING DONOR NEPHRECTOMY, ETHICON ATW35 STAPLER RELOAD FAILED TO COMPLETELY LIGATE THE RENAL ARTERY. STAPLES FIRED ON THE ORGAN SIDE OF THE RELOAD. THE PT SIDE ONLY PARTIALLY FIRED. THEN, THE DEVICE CUT THE VESSEL AS INTENDED. THE RESULT AS A PARTIALLY OPEN RENAL ARTERY THAT HAD TO BE MANUALLY LIGATED. STEPS TO ACHIEVE THIS RESULT INCLUDED CONVERTING TO AN OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706835 ETHICON ARTICULATING LINEAR CUTTER GDW JOHNSON AND JOHNSON ATW35 L92E87
    706836 ETHICON ARTICULATING LINEAR CUTTER GDW JOHNSON AND JOHNSON TR35W L4EZ2C

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| L| R