BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1445478 · Received August 19, 2009

    Report

    Report Number
    1219930-2009-00555
    Event Type
    Injury
    Date Received
    August 19, 2009
    Date of Event
    July 1, 2009
    Report Date
    July 2, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 08/18/2009.

    Description of Event or Problem · 1

    PROCEDURE: LAP APPENDECTOMY. ACCORDING TO THE REPORTER: THE ENDO GIA MISFIRED SEVERAL ADDITIONAL SULU WERE APPLIED TO CORRECT THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GDW NORTH HAVEN - USS N9D0680

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ENDO GIA ROTICULATOR 60-3.5 SULU| MANUFACTURE DATE: 01/2009| LOT NUMBER: N9A418