BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL XL STAPLER

    MDR report key: 1933010 · Received December 10, 2010

    Report

    Report Number
    1219930-2010-00943
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 7, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: THE STAPLE LINE TORE THE MUCOSA OF THE STOMACH. THE SURGEON CHANGED TO ANOTHER DEVICE AND RESECTED MORE TISSUE LATERAL TO THE FIRST FIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA ULTRA UNIVERSAL XL STAPLER DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0H0299UJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability EGIA 60 ARTICULATING MED/THICK SULU,| EGIA 60AMT| MANUFACTURE DATE: 05/2010| LOT NUMBER: N0E0166UL, EXP DATE: 05/31/2015,