BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 1822676 · Received September 1, 2010

    Report

    Report Number
    3005075853-2010-05018
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 8, 2010
    Report Date
    August 10, 2010
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE, THE KNIFE WAS NOT RETURNED TO THE HOME POSITION EVEN THOUGH THE RELEASE LEVER WAS USED AFTER THE THIRD FIRING. THE DEVICE WAS RELEASED SOMEHOW BY REMOVING THE TISSUE FROM THE JAW. REINFORCEMENT MATERIAL WAS NOT USED. THE DEPLOYED STAPLES WERE FORMED PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE CUSTOMER DISPOSED OF THE DEVICE, NO DEVICE WILL BE RETURNING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD PRODUCT #- (B)(4)