BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY INC

    MDR report key: 1701732 · Received May 25, 2010

    Report

    Report Number
    MW5016093
    Event Type
    Injury
    Date Received
    May 25, 2010
    Date of Event
    May 14, 2010
    Report Date
    May 17, 2010
    Manufacturer
    ETHICON-ENDO SURGERY, INC.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ROBOT PARTIAL NEPHRECTOMY TURNED RADICAL NEPHRECTOMY DUE TO LAPAROSCOPIC CLIP APPLIER NOT RELEASING TISSUE AND MISFIRED A CLIP, THUS DAMAGING THE RENAL ARTERY/VEIN RESULTING IN HAVING TO LIGATE THE VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY INC CLIP APPLIER / 5 MM GDO ETHICON-ENDO SURGERY, INC. REF EL5ML G4RZ0W

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention