BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA UNIVERSAL

    MDR report key: 1822816 · Received August 30, 2010

    Report

    Report Number
    1219930-2010-00685
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 23, 2010
    Manufacturer
    UNITED STATES SURGICAL
    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

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: APPENDECTOMY. ACCORDING TO THE REPORTER: ON THE FIRST FIRING, THE JAWS WOULD NOT OPEN. ADDITIONAL RESECTION WAS DONE TO REMOVE FROM THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA UNIVERSAL NONE GDW UNITED STATES SURGICAL N0E0690

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 030458, ENDO GIA ROTICULATOR 60-3.5 SULU