BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 28MM SINGLE-USE STAPLER

    MDR report key: 2001712 · Received February 22, 2011

    Report

    Report Number
    2647580-2011-00120
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 16, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    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 TYPE: LAPAROSCOPICALLY ASSISTED COLECTOMY. ACCORDING TO THE REPORTER: THE ANVIL DISCONNECTED FROM THE INSTRUMENT AFTER FIRING, AT THE HEIGHT OF 30CM. IT TOOK 2 HOURS FOR THE DOCTOR TO TAKE IT OUT OF THE BODY. THE FIRING WAS O.K., AND THE PT IS NOW AT HOME. THE OPERATING ROOM TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA XL 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW USSC PUERTO RICO P0F0714H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other