BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12 MM SINGLE USE INST

    MDR report key: 1822811 · Received August 30, 2010

    Report

    Report Number
    1219930-2010-00684
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 25, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: COLECTOMY. THE INSTRUMENT STAPLED BUT DID NOT CUT AND THE INSTRUMENT COULD NOT BE REMOVED FROM TISSUE. THE DEVICE WAS RESECTED WITH ANOTHER INSTRUMENT AND PLACEMENT OF TWO ADDITIONAL PORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12 MM SINGLE USE INST DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0D0528

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability