BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2222533 · Received August 25, 2011

    Report

    Report Number
    3005075853-2011-03495
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 2, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT ONE EC60 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD PRESENT.THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING A THORACIC PROCEDURE, THERE WERE DIFFICULTIES TO OPEN THE DEVICE. THE SURGEON PLACED THE FIRST GREEN RELOAD IN THE DEVICE (ECR60G) AND AFTER THE FIRST STAPLING, THE DEVICE WOULD NOT OPEN. THE DEVICE WAS NOT FIRED NEXT TO AN EXISTING STAPLE LINE. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43D3V

    Patients

    Seq Age Sex Outcome Treatment
    1