BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA UNIVERSAL

    MDR report key: 6085219 · Received November 8, 2016

    Report

    Report Number
    6085219
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 2, 2016
    Manufacturer
    COVIDIEN
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STAPLER FAILED TO FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736751 ENDO GIA ULTRA UNIVERSAL STAPLE, IMPLANTABLE GAG COVIDIEN P6F0309X/N6H0173UX

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR