BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 25MM SINGLE-USE STAPLER

    MDR report key: 3874802 · Received May 30, 2014

    Report

    Report Number
    2647580-2014-00432
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 27, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: WHEN CONNECTING THE PRESSURE PLATE OF ORVIL, THERE WAS NO AUDIBLE FEEDBACK AND THE ANVIL DID NOT FLIP UP TO 90 DEGREES. WITH DIFFICULTY AND FORCE, THE INSTRUMENT COULD BE CLOSED AND FIRED. THE DOCTOR USED ANOTHER INSTRUMENT WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319053 EEA XL 25MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC P2K0044X

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other