BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 1944324 · Received January 3, 2011

    Report

    Report Number
    3005075853-2011-00027
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    November 15, 2010
    Report Date
    November 16, 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). THE SC60 DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH TWO RELOADS PRESENT. RELOAD B WAS RECEIVED PARTIALLY FIRED 1/16. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD, LOCKING THE CARTRIDGE AND PUSHING STAPLES UPWARDS. RELOAD C WAS RECEIVED PARTIALLY FIRED 1/2, A PARTIAL FIRE CAN OCCUR IF THE FIRING SEQUENCE IS INTERRUPTED, THE DEVICE IS OPENED, THEN CLOSED AND FIRING IS RESUMED, CAUSING THE INSTRUMENT TO LOCK OUT. THE RETURNED CARTRIDGE RELOADS B AND C WERE TESTED FOR FUNCTIONALITY BY RESETTING AND RELOADING IT INTO THE DEVICE. THE FUNCTIONAL TEST DEMONSTRATED THAT THE REMAINING STAPLES IN THE CARTRIDGE RELOAD FORMED PROPERLY AND THE INSTRUMENT ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, THE FIRING TRIGGER BECAME NOT TO BE GRASPED ON THE WAY WHEN THE DEVICE WAS FIRED ON THE BRONCHIAL TUBES AT THE FIRST FIRING. ALTHOUGH THE CARTRIDGE WAS REPLACED, THE FIRING TRIGGER BECAME NOT TO BE GRASPED IN THE SAME WAY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TW6P

    Patients

    Seq Age Sex Outcome Treatment
    1