BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON

    MDR report key: 2643291 · Received June 28, 2012

    Report

    Report Number
    MW5026027
    Event Type
    Death
    Date Received
    June 28, 2012
    Date of Event
    May 2, 2012
    Report Date
    June 25, 2012
    Manufacturer
    ETHICON LLC/JOHNSON+JOHNSON
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A SURGICAL PROCEDURE. THE STAPLER CEEA DID NOT FUNCTION AS ANTICIPATED. IT TOOK MORE TORQUE TO GET IT TO THE "GREEN ZONE". THE NORMAL TACTILE SENSATION WAS NOT FELT AND THE SOUND THE DEVICE NORMALLY MAKES WAS NOT HEARD. THE DEVICE WAS WITHDRAWN AND HAD TISSUE IN IT. THE STAPLER MAY HAVE MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOSCOPIC STAPLER GDW ETHICON LLC/JOHNSON+JOHNSON ECS25 ENDOSCOPIC STAPLER E4LY53

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| R