BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1063300 · Received June 19, 2008

    Report

    Report Number
    1219930-2008-00468
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 12, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: COLECTOMY. ACCORDING TO THE REPORTER: THE FIRST FIRING WITH 3.5MM STAPLES FELT TIGHT AND THE ANVIL WAS BENT UPON REMOVAL THROUGH THE TROCAR. THE SURGEON MOVED UP TO 4.8MM STAPLES FOR THE SECOND FIRING AND STATED THE STAPLES DID NOT FORM. UPON VISUAL INSPECTION, THE ANVIL WAS SLIGHTLY BENT. THE SURGEON CONVERTED TO OPEN COLECTOMY, OVERSEWED THE STAPLE LINE AND CLOSED UP.

    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 Required Intervention ENDO GIA ROTICULATOR 60-3.5 SULU| ENDO GIA ROTICULATOR 60-4.8 SULU