BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1522798 · Received November 4, 2009

    Report

    Report Number
    1219930-2009-00751
    Event Type
    Injury
    Date Received
    November 4, 2009
    Date of Event
    April 29, 2009
    Report Date
    November 3, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 11/04/2009.

    Description of Event or Problem · 1

    PROCEDURE: LAP APPENDECTOMY. ACCORDING TO THE REPORTER: THE INSTRUMENT WOULD NOT RELEASE FROM TISSUE. ANOTHER DEVICE WAS USED TO RESECT THE INSTRUMENT.

    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 N9A95

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability