BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1062568 · Received June 18, 2008

    Report

    Report Number
    1219930-2008-00434
    Event Type
    Death
    Date Received
    June 18, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAP GASTRIC BYPASS. ACCORDING TO THE RPTR: WHILE THE SURGEON WAS FIRING THE DEVICE, THE LOAD'S EYEBEAM BROKE HALFWAY THROUGH THE FIRING. NO REPORTED PIECES MISSING. THE SURGEON OPENED UP A SECOND HANDLE AND LOAD TO CONTINUE THE PROCEDURE. WHILE FIRING, IT CRACKED. THE SURGEON OPENED UP A NEW HANDLE WITH ANOTHER LOAD AND WAS ABLE TO COMPLETE THE CASE WITHOUT INCIDENT. THE PT EXPIRED APPROX 1 HR AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS N8D37

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death EXP DATE: 03/31/2013, MFR DATE: 03/2008| ENDO GIA II 45-3.5 DLU, LOT N8C86