BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA UNIVERSAL

    MDR report key: 1772155 · Received July 22, 2010

    Report

    Report Number
    1219930-2010-00564
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 15, 2010
    Report Date
    July 16, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP APPENDECTOMY. ACCORDING TO THE REPORTER: THE DEVICE MISFIRED SEVERAL TIMES CAUSING A TWO HOUR DELAY IN OPERATIVE TIME. NO ADDITIONAL BLOOD LOSS REPORTED. NO OTHER INFORMATION PROVIDED AT THE TIME OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA UNIVERSAL DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0F0224

    Patients

    Seq Age Sex Outcome Treatment
    1 Other