BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL XL STAPLER

    MDR report key: 2190457 · Received July 29, 2011

    Report

    Report Number
    1219930-2011-00631
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 18, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: THE STAPLER BROKE DURING FIRING AND A REPLACEMENT HANDLE ALSO BROKE CAUSING A LARGE DELAY IN THE CASE GREATER THAN 30 MINUTES. A 3RD HANDLE WAS OPENED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA ULTRA UNIVERSAL XL STAPLER DISPOSABLE STAPLER GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DUET TRS 60.4 4.8MM STRAIGHT SULU: CAT# DUET6048| (B)(4)