BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 25MM SINGLE-USE STAPLER

    MDR report key: 2922501 · Received January 14, 2013

    Report

    Report Number
    2647580-2013-00018
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 18, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ROUX-EN-Y. ACCORDING TO THE REPORTER: THE TISSUE WAS NOT CUT UPON PERFORMING ESOPHAGO JEJUNOSTOMY. THE ANVIL WAS PLACED IN THE ESOPHAGUS AND THE DEVICE WAS INSERTED INTO JEJUNUM. AFTER FIRING, THE DEVICE COULD NOT BE REMOVED AND THE SURGEON GRASPED THE ORAL SIDE OF THE ESOPHAGUS WITH PSI FORCEPS AND CUT THE TISSUE TO REMOVE THE DEVICE. ANASTOMOSIS WAS PERFORMED AGAIN WITH A NEW EEA25. NO REINFORCEMENT MATERIAL WAS USED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS UNANTICIPATED TISSUE LOSS. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19769 EEA 25MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY USSC P2G0624X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other