BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-3.5 SULU

    MDR report key: 1832012 · Received September 8, 2010

    Report

    Report Number
    2647580-2010-00758
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: PANCREAS. ACCORDING TO THE REPORTER: STAPLES DID NOT FORM PROPERLY. ADDITIONAL RESECTION WAS DONE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    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 P0E0963

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability