BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 4088617 · Received July 25, 2014

    Report

    Report Number
    4088617
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    May 5, 2014
    Report Date
    July 25, 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 LAPAROSCOPIC SLEEVE GASTRECTOMY. THE SURGEON USED THE ENDO GIA STAPLER (ENDO GIA ULTRA UNIVERSAL STAPLER, REF # EGIAUXL, LOT # P3M0525X) WITH THE FIRST LOAD WHILE STAPLING THE STOMACH WITHOUT ISSUE. WHEN THE SCRUB TECH ATTEMPTED TO APPLY THE SECOND LOAD ONTO THE ENDO GIA HANDLE, IT WOULD NOT LOAD. THE HANDLE WAS REPLACED AND LOADED WITHOUT DIFFICULTY. NO PATIENT HARM.======================MANUFACTURER RESPONSE FOR SURGICAL STAPLER, ENDO GIA ULTRA UNIVERSAL STAPLER (PER SITE REPORTER)======================NO KNOWN RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437419 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN * P3M0525X

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR COVIDIEN ENDO GIA BLACK ARTICULATING RELOAD