BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA STAPLER LOAD

    MDR report key: 1203805 · Received September 29, 2008

    Report

    Report Number
    1203805
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 21, 2008
    Manufacturer
    COVIDIEN (UNITED STATES SURGICAL CORP)
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ENDO GIA STAPLER PUT UP ONTO STERILE FIELD, ALONG WITH ENDO GIA LOAD 30-2.5. SCRUB TECH PUT IT TOGETHER. THE INSTRUMENT DID NOT CLOSE PROPERLY WHEN BEING CYCLED AND PREPARED FOR SURGEONS. A NEW RELOAD WAS GIVEN UP AND THE UNUSED LOAD WAS PASSED OFF THE FIELD AND PLACED IN A BIOHAZARD BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA STAPLER LOAD STAPLER, SURGICAL GDW COVIDIEN (UNITED STATES SURGICAL CORP) NA N8F173

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR