BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA UNIVERSAL

    MDR report key: 1872582 · Received October 1, 2010

    Report

    Report Number
    1872582
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 13, 2010
    Report Date
    October 1, 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

    ENDO STAPLER DID NOT FIRE, TWO (2) RELOADS WOULD NOT WORK AND THEY WERE REPLACED WITH AN OLDER STYLE STAPLER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR