BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1221343 · Received October 26, 2008

    Report

    Report Number
    1221343
    Event Type
    Malfunction
    Date Received
    October 26, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 26, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING A TA 60 4.8MM STAPLER, NOT ALL OF THE STAPLES DEPLOYED DURING FIRING WHICH CAUSED BLEEDING. THE CUT END OF THE PANCREAS WAS OVER SEWN USING A RUNNING LOCKING SUTURE. AT THIS POINT, THE ABDOMEN WAS IRRIGATED WITH TWO LITERS OF WARM NORMAL SALINE. THERE WAS NO EVIDENCE OF BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * STAPLER, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * P7H0376

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR