BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1060422 · Received June 12, 2008

    Report

    Report Number
    1219930-2008-00446
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 5, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE SURGEON STATED THAT THE STAPLES DID NOT FORM BUT THE KNIFE BLADE CUT. THERE WAS A GASTROTOMY NOTED AND THERE WERE STAPLES EVIDENT THAT DEPLOYED BUT DID NOT FORM INTO A B. EXTRA STAPLE FIRINGS WERE APPLIED TO CLOSE THE GASTROTOMY AND CREATE A POUCH. APPROXIMATELY 20 MINUTES WAS ADDED TO THE PROCEDURE.

    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