BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA UNIVERSAL

    MDR report key: 1960022 · Received January 5, 2011

    Report

    Report Number
    1960022
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 5, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    STAPLER WOULDN'T OPEN WHEN THE TISSUE WAS IN THE CLAMP. HAD TO CAUTERIZE TO RELEASE CLAMP FROM PATIENT. CLAMP JAWS WITH TISSUE PLACED IN PRODUCT BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL STAPLER, SURGICAL GDW COVIDIEN 030449 N9K0096

    Patients

    Seq Age Sex Outcome Treatment
    1 *