BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 25MM SINGLE-USE STAPLER

    MDR report key: 3063696 · Received March 28, 2013

    Report

    Report Number
    2647580-2013-00168
    Event Type
    Injury
    Date Received
    March 28, 2013
    Report Date
    March 5, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE ANASTOMOSIS OF THE SMALL INTESTINE AT THE STOMACH POUCH WAS MADE WITH AN EEA. TILT-TOP WAS TURNED DOWN AND COULD NOT BE REMOVED ANYMORE. AT THE RETRIEVAL WITH FORCE, 3/4 OF THE ANASTOMOSIS WAS LOOSENED. AGAIN AN ANASTOMOSIS HAD TO BE MADE WITH EEA AND ORVIL. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127600 EEA XL 25MM SINGLE-USE STAPLER DISPOSABLE STAPLING DEVICE GAG COVIDIEN, FORMERLY USSC P2H0713X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other