BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 3518424 · Received October 23, 2013

    Report

    Report Number
    3518424
    Event Type
    Malfunction
    Date Received
    October 23, 2013
    Date of Event
    October 3, 2013
    Report Date
    October 23, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING COVIDIEN ENDO GIA STAPLER, 30MM VASCULAR LOAD GIVEN AND MALFUNCTIONED. ITEM REMOVED FROM FIELD, PLACED IN ORIGINAL PACKAGE AND RED BAGGED. VENDOR MADE AWARE. REF# 030451/ LOT# N3E0037LX/ EXP DATE 2018-05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544402 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE * N3E0037LX

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR