BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-3.5 SULU

    MDR report key: 1844815 · Received September 22, 2010

    Report

    Report Number
    2647580-2010-00778
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 8, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: BARIATRIC PROCEDURE. ACCORDING TO THE RPTR: STAPLES DID NOT FORM PROPERLY. THERE WAS FLUID LEAKAGE. ANOTHER DEVICE WAS APPLIED FOR RESECTION OF ADD'L TISSUE. THE CASE WAS EXTENDED BY APPROX 40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 60-3.5 SULU DISPOSABLE STAPLER GDW USSC PUERTO RICO P9J0197

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability