BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 3951907 · Received July 11, 2014

    Report

    Report Number
    3951907
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 11, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    A COVIDIEN UNIVERSAL HAND PIECE ENDO GIA WAS OPENED REF# EGIAUSTND LOT #P4A0163X AND A FIRST ARTICULATING LOAD REF# 030453 45MM-2.0 GRAY LOAD LOT# N3C0292LX FIRED CORRECTLY. HOWEVER THE NEXT RELOAD THE (SAME KIND) WITH LOT# N3F0179LX ONLY FIRED HALF WAY AND PIECES CAME OFF INSIDE THE PATIENT AND THEY HAD TO FORCE RELEASE IT TO GET IT OFF OF HANDPIECE. A NEW UNIVERSAL HAND PIECE LOT# P4D0078X WAS OPENED AND A NEW LOAD LOT # N3F0179LX(SAME KIND) WAS OPENED AND ONCE AGAIN THE STAPLER ONLY FIRED HALF WAY AND THE LOAD WOULD NOT RELEASE AND IT HAD TO BE FORCE RELEASED AGAIN. THE REP FOR COVIDIEN WAS BROUGHT IN AS WELL AS THE OR MANAGER TO EVALUATE THE SITUATION. THE SURGEONS OPENED ANOTHER HANDPIECE AND RELOAD; THIS PARTIALLY CONTROLLED BLEEDING. ALSO ENDO CLIPS WERE OPENED TO STOP BLEEDING BECAUSE THE VESSEL WAS ONLY PARTIALLY STAPLED AT FIRST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407561 EGIA ULTRA UNIVERSAL STAPLER STAPLE, IMPLANTABLE GDW COVIDIEN * P4A0163X
    407562 EGIA ULTRA UNIVERSAL STAPLER STAPLE, IMPLANTABLE GDW COVIDIEN * P4D0078X
    407563 ENDO GIA UNIVERSAL ROTICULATOR STAPLE, IMPLANTABLE, RELOAD GDW COVIDIEN 45-2.0 BX N3C0292LX
    407564 ENDO GIA UNIVERSAL ROTICULATOR STAPLE, IMPLANTABLE, RELOAD GDW COVIDIEN 45-2.0 BX N3F0179LX

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR