BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 3993976 · Received July 23, 2014

    Report

    Report Number
    3993976
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    March 31, 2014
    Report Date
    July 23, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A LAPAROSCOPIC SLEEVE GASTRECTOMY. THE SURGEON WAS USING MULTIPLE LOADS OF COVIDIEN ENDO GIA STAPLES. THIS PARTICULAR STAPLE LOAD (ENDO GIA BLACK ARTICULATING RELOAD WITH TRI-STAPLE TECHNOLOGY, 45MM EXTRA THICK, REF # EGIA45AXT, LOT # N3L0863GX) WOULD NOT SEAT CORRECTLY ONTO THE GIA HANDLE, THEREFORE WAS UNUSABLE. THE STAPLE LOAD WAS REPLACED.======================MANUFACTURER RESPONSE FOR SURGICAL STAPLES, ENDO GIA BLACK ARTICULATING RELOAD WITH TRI-STAPLE TECHNOLOGY (PER SITE REPORTER).======================NO KNOWN RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431793 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN * N3L0863GX

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER