BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER

    MDR report key: 3232384 · Received June 12, 2013

    Report

    Report Number
    3232384
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    October 23, 2012
    Report Date
    June 12, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL, A DIVISION OF TYCO HEALTHCARE
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    12MM XL UNIVERSAL STAPLER (EGIAUXL) AND 60MM TAN RETICULATING RELOADS (EGIA60)X 2 FAILED TO FIRE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267280 COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER STAPLER, SURGICAL GDW COVIDIEN, FORMERLY US SURGICAL, A DIVISION OF TYCO HEALTHCARE * *
    267281 COVIDIEN ENDO GIA 60MM RELOAD STAPLE, SURGICAL, RELOAD GDW COVIDIEN, FORMERLY US SURGICAL, A DIVISION OF TYCO HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR NO OTHER THERAPIES