BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIA STAPLER

    MDR report key: 4091778 · Received July 25, 2014

    Report

    Report Number
    4091778
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 25, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER THE STAPLER HAD FIRED SEVERAL TIMES, IT WAS LOADED, IT WOULD NOT FIT DOWN THE TROCAR AT FIRST. STAFF FINALLY GOT IT TO GO DOWN ANOTHER TROCAR. ONCE IT WAS RELOADED, IT WOULD NOT DO WHAT IT WAS SUPPOSED TO DO. IT KEPT POPPING AND THE RELOAD JUST DIDN'T SEEM TO FIT IN THE GUN CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437103 GIA STAPLER STAPLE, IMPLANTABLE GDW COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR