BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIA UNIVERSAL

    MDR report key: 1070569 · Received June 24, 2008

    Report

    Report Number
    1070569
    Event Type
    Malfunction
    Date Received
    June 24, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 24, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    DURING A COLORECTAL ANASTOMOSIS PROCEDURE THE UNIVERSAL GIA RELOAD STUCK AND MALFUNCTIONED. THE RELOAD HAD TO BE PRIED OPEN TO GET THE RELOAD OFF THE BOWEL. THIS RESULTED IN THE SURGEON HAVING TO RESECT TWO MORE PORTIONS OF SMALL BOWEL. REP. CONTACTED AND SPOKE WITH SURGEON. DEVICE RETAINED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA UNIVERSAL STAPLER, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL CORPORATION 030403 N8B343

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR NO OTHER THERAPIES| NO OTHER THERAPIES