BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 21MM SINGLE-USE STAPLER

    MDR report key: 2202445 · Received August 5, 2011

    Report

    Report Number
    1219930-2011-00661
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 29, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: THE DEVICE MISFIRED. THE STAPLES WERE NOT FORMED PROPERLY AND IT WAS DIFFICULT TO REMOVE THE DEVICE FROM THE PT. THE ANASTOMOSIS WAS RESECTED, AN ORVVIL ANVIL HAD TO BE USED DUE TO THE SMALL AMOUNT OF SPACE AT THE POUCH, AND IT WAS THEN OVER SEWN- ALL ADDING A SIGNIFICANT AMOUNT OF THE TIME TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA XL 21MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL N0B0779UH

    Patients

    Seq Age Sex Outcome Treatment
    1