BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 2133646 · Received June 8, 2011

    Report

    Report Number
    1219930-2011-00488
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 26, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: APPENDECTOMY. ACCORDING TO THE REPORTER: THE PT WAS SEEN A MONTH PRIOR FOR AN INFLAMED APPENDIX. WAS IN SURGERY ON (B)(6) 2011 AND SCAR TISSUE HAD FORMED. THE STAPLER WAS PLACED ON THE APPENDIX TISSUE AND THE STAPLER T FIRED WITHOUT DIFFICULTY. TISSUE WAS REPORTEDLY NOT TOO THICK. WHEN THE STAPLER WAS OPENED IT WAS NOTICED THAT THERE WAS A 1-2CM GAP IN THE STAPLE LINE. ANOTHER INSTRUMENT WAS USED TO RE-STAPLE THE LINE. THERE IS NO REPORT OF BLOOD LOSS AND NO TISSUE DAMAGE OR LOSS. THE PT IS FINE. NOTHING FELL IN THE SURGICAL CAVITY. THE SURGERY WAS EXTENDED 1 HOUR. THE SAMPLE IS BEING SENT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N9K0006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other