BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 3831884 · Received May 16, 2014

    Report

    Report Number
    3831884
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 16, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    TWO WHITE 30/2.5MM LOADS WERE USED ON ENDO GIA STAPLER AND LOADED EASILY. UPON FIRING BOTH LOADS, STAPLER MADE A LOUD "POPPING" SOUND. STAPLES APPEARED TO HAVE BEEN DEPLOYED CORRECTLY. NO HARM TO PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293606 ENDO GIA STAPLER GDW COVIDIEN * N3K1747
    293607 ENDO GIA STAPLE GDW COVIDIEN 30X2.5MM WHITE N3DO330LX
    293608 ENDO GIA STAPLE GDW COVIDIEN 30X2.5MM WHITE N3DO330LX

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR