BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX

    MDR report key: 3120058 · Received May 9, 2013

    Report

    Report Number
    3120058
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    STAPLER WAS BEING USED FOR THORACOSCOPIC APICAL PULMONARY BLEB RESECTION. SURGEON INTRODUCED THE LOADED INSTRUMENT LAPAROSCOPICALLY AND POSITIONED IT TO STAPLE THE BLEB. DEVICE FAILED TO FIRE ON FIRST FIRING OF INSTRUMENT. THE DEVICE WAS REPLACED WITH ANOTHER AND NO INJURY TO THE PATIENT WAS SUSTAINED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THORACOSCOPIC APICAL PULMONARY BLEB RESECTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205027 ECHELON FLEX STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. SC45A H44Z20

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR ECHELON 45 ECR45G, LOT H4411F, 2016-05