BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1219500 · Received November 3, 2008

    Report

    Report Number
    1219930-2008-00798
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 3, 2008
    Manufacturer
    NORTH HAVEN - USS
    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

    INITIAL REPORT SENT TO FDA ON 11/03/2008.

    Description of Event or Problem · 1

    PROCEDURE: VATS. ACCORDING TO THE REPORTER: THE STAPLER FIRED ON THE VESSEL BUT COULD NOT BE RELEASED. THE SURGEON SUTURED AROUND THE VESSEL WHERE THE CARTRIDGE WAS LOCKED AND RESECTED. THE SURGEON OPENED A NEW DEVICE TO COMPLETE THE CASE. OR TIME WAS DELAYED 15 MINUTES. RELEVANT MEDICAL HISTORY COULD NOT BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability