BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1890025 · Received November 1, 2010

    Report

    Report Number
    1219930-2010-00822
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 28, 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. ACCORDING TO THE REPORTER: AFTER STAPLING, THE DEVICE WAS JAMMED IN THE TROCAR. WHEN THE INSTRUMENT WAS PULLED, A METAL PART CAME OFF AND REMAINED IN THE ABDOMEN. THE SURGEON RETRIEVED THE METAL PART. THE OPERATION LASTED 7 HOURS INSTEAD OF 3.

    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 N0E0150

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability