BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA UNIVERSAL

    MDR report key: 1233966 · Received November 14, 2008

    Report

    Report Number
    1219930-2008-00826
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 24, 2008
    Report Date
    November 6, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 11/13/08.

    Description of Event or Problem · 1

    PROCEDURE: ILEOCECAL RESECTION. ACCORDING TO THE REPORTER: WHILE FIRING, THE HANDLE LOCKED UP AND THE INSTRUMENT COULD NOT FIRE COMPLETELY. TISSUE WAS RESECTED WITH ANOTHER DEVICE TO RECOVER. PT STATUS WAS REPORTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA UNIVERSAL NONE GDW NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 030414