BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 1842650 · Received September 20, 2010

    Report

    Report Number
    MW5017508
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 2, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE EXPLORATORY LAPAROTOMY SURGERY, THE MD WAS USING A GIA 60 STAPLER ON THE PT. WHEN HE FIRED THE STAPLER, HE NOTICED THE PT BLEEDING FROM THE STAPLE LINE. WHEN THE OOZING STOPPED, THE SURGERY CONTINUED WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN AUTO SUTURE GDO COVIDIEN GIA6038S

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR