BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 1951823 · Received November 12, 2010

    Report

    Report Number
    1951823
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    September 29, 2010
    Report Date
    November 12, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ENDO GIA STAPLER COULD NOT AND DID NOT PROPERLY FIRE. THE PROBLEM IS THE STAPLE LOADS ARE INADEQUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA STAPLER, SURGICAL GDW COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR