BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 28MM SINGLE USE STAPLER WITH

    MDR report key: 3894045 · Received June 18, 2014

    Report

    Report Number
    2647580-2014-00451
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLORECTAL. ACCORDING TO THE REPORTER: AFTER THE EEAXL2835 WAS SUCCESSFULLY FIRED, A LEAK TEST WAS PERFORMED AND A STEADY STREAM OF BUBBLES ROSE ANTERIOR FROM THE ANASTOMOTIC SITE. THE COLON WAS TRANSECTED AGAIN USING A CONTOUR AND THEN RECONNECTED WITH A EEAXL2835. AGAIN, THE DONUTS LOOKED GREAT. UPON A SECOND TIME, A LEAK TEST WAS PERFORMED AND A STEADY STREAM OF BUBBLES ROSE ANTERIOR FROM THE ANASTOMOTIC SITE. THE ANASTOMOTIC SITE WAS REINFORCED WITH SUTURE AND TESTED SATISFACTORILY. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. THERE WAS NO DELAY OVER 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359044 EEA XL 28MM SINGLE USE STAPLER WITH DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC P2C0002H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other