BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL XL STAPLER

    MDR report key: 2896070 · Received December 27, 2012

    Report

    Report Number
    1219930-2012-01014
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 29, 2012
    Manufacturer
    COVIDIEN, FORMERLY U.S. SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    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 TYPE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: AFTER SURGERY, THE STAPLES RELEASED AND REQUIRED A SECOND OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA ULTRA UNIVERSAL XL STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY U.S. SURGICAL N2E0409UX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other