BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 25MM SINGLE-USE STAPLER

    MDR report key: 3212761 · Received July 1, 2013

    Report

    Report Number
    2647580-2013-00366
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    April 30, 2013
    Report Date
    June 27, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: VATS. ACCORDING TO THE REPORTER. THE EEA STAPLER BROKE WHILE IN PT. MD REQUIRED TO DO OPEN THORACOTOMY TO COMPLETE ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298017 EEA 25MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P1C0908H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other