BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 28MM SINGLE-USE STAPLER

    MDR report key: 3143176 · Received May 24, 2013

    Report

    Report Number
    2647580-2013-00296
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: COLORECTAL. ACCORDING TO THE REPORTER: DURING THE RECTUM RESECTION. WHEN THEY ACTIVATED THE DEVICE WORKED CORRECTLY; IT CUT AND STAPLED. HOWEVER, WHEN THEY BEGAN TO OPEN IT IN ORDER TO REMOVE IT, THE ANVIL GOT LOOSE AND REMAINED IN THE PATIENT CAVITY, STILL TILTED. AS THEY THOUGH THAT TO REMOVE IT COULD DAMAGE THE ANASTOMOSIS, THEY PERFORMED A COLOSTOMY TO EXTRACT IT. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230967 EEA XL 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P1A0605H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other