BEUDAMED
    FDA Adverse Event Other Summary report: N

    COVIDIEN, UNITED STATES SURGICAL

    MDR report key: 2554408 · Received June 18, 2010

    Report

    Report Number
    2554408
    Event Type
    Other
    Date Received
    June 18, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 10, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    TITLE: ERS (B)(4), STAPLER. STAPLE FAILURE LED TO ADDITIONAL BLEEDING INTRA-OP. FURTHER SURGERY WAS PERFORMED BECAUSE OF BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN, UNITED STATES SURGICAL DISPOSABLE SURGICAL STAPLER GDW UNITED STATES SURGICAL TA 30

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR