BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1844822 · Received September 22, 2010

    Report

    Report Number
    1219930-2010-00734
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 6, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: APPENDECTOMY. ACCORDING TO THE RPTR: THE DLU COULD NOT BE OPENED AFTER FIRING. THE INSTRUMENT WAS RESECTED WITH THE USE OF ANOTHER DEVICE. SURGERY TIME EXTENSION WAS REPORTED AS 20 MINUTES.

    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 N0D0358

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability LOT NUMBER: N0E0428, EXPIRATION DATE: 05/31/2015| ENDO GIA ROTICULATOR 30-3.5 SULU, (B)(4),