BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIA 80 3.5MM BLUE

    MDR report key: 1182224 · Received September 12, 2008

    Report

    Report Number
    1182224
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    June 11, 2008
    Report Date
    September 12, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING ILEOSTOMY CLOSURE. SURGEON ASKED FOR BLUE GIA 80. AFTER USING THE DEVICE FOR ANASTOMOSIS THERE WAS A LEAK ALONG THE SUTURE LINE. THE SALES REP WAS CONTACTED OVER THE PHONE AND WAS UNABLE TO COME TO THE FACILITY. A NEW STAPLER WAS OBTAINED BY A SUPERVISOR. THE SURGEON USED THE NEW STAPLER TO REINFORCE THE SUTURE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA 80 3.5MM BLUE STAPLER, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL * P8D0991

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR