BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY INC

    MDR report key: 1711483 · Received May 25, 2010

    Report

    Report Number
    MW5016164
    Event Type
    Injury
    Date Received
    May 25, 2010
    Date of Event
    April 15, 2010
    Report Date
    May 20, 2010
    Manufacturer
    ETHICON-ENDO SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLER MISFIRED PER SCRUB TECH. SAME LOT NUMBER ON BOTH STAPLERS. NO PT ADVERSE EFFECTS THAT ARE KNOWN. THIRD STAPLER GIVEN TO THE PHYSICIAN DID NOT MISFIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY INC STAPLER ARTICULATING ENDOSCOPIC GDW ETHICON-ENDO SURGERY, INC. G4RF4X

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention