BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-4.8 SULU

    MDR report key: 1900106 · Received November 9, 2010

    Report

    Report Number
    1219930-2010-00835
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: REVISION LAP BAND. ACCORDING TO THE REPORTER: THE STAPLER MISFIRED WHEN TAKING THE SECOND BITE TO CREATE THE GASTRIC POUCH. TISSUE WAS POSSIBLY TOO THICK OR STAPLER WAS FIRED ACROSS EG TUBE. THE PROCEDURE WAS CONVERTED TO OPEN. ANOTHER DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-4.8 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention