BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1760410 · Received July 13, 2010

    Report

    Report Number
    1219930-2010-00546
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 12, 2010
    Manufacturer
    UNITED SATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP APPENDECTOMY. ACCORDING TO THE REPORTER: ON THE SECOND FIRING THE JAWS LOCKED ON TISSUE. THE DOCTOR HAD TO USE A 5MM CLIP APPLIER TO TRANSACT THE AREA AROUND THE 030449 WHICH MADE IT POSSIBLE TO REMOVE. OPERATIVE TIME WAS DELAYED BY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GDW UNITED SATES SURGICAL N0D0464

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability