BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA INSTRUMENT

    MDR report key: 1241538 · Received November 21, 2008

    Report

    Report Number
    1219930-2008-00852
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 23, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: THE SURGEON COULD NOT PULL THE BLACK RETURN KNOBS BACK TO OPEN THE JAWS. THE JAWS WERE RELEASED BY MANIPULATION. ANOTHER DEVICE WAS APPLIED AND ADDITIONAL TISSUE WAS RESECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ENDO GIA INSTRUMENT DISPOSABLE STAPLER GDW NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability