BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3840231 · Received May 30, 2014

    Report

    Report Number
    3005075853-2014-03665
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 18, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: PREMATURE SLED MOVEMENT, DAMAGED PAWL. THE ANALYSIS FOUND THAT ONE PSE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH THE MANUAL OVERRIDE DOOR OUT OF POSITION AND MISSING; THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. IT SHOULD BE NOTED AFTER THE MANUAL OVERRIDE SYSTEM IS USED THE INSTRUMENT IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENCE FIRINGS. AN ECR60D CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED 1/16 AND LOADED IN THE DEVICE. 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 AND LOCKING THE CARTRIDGE. THE DEVICE WAS DISASSEMBLED TO RESET THE MANUAL OVERRIDE SYSTEM; THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND THEN, THE KNIFE ONLY ADVANCED A FEW MILLIMETERS AND THE FIRING STOPPED. THE KNIFE REVERSE BUTTON WAS ACTIVATED AND THE KNIFE RETURNED TO HOME AS INTENDED. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE PAWL BAILOUT WAS FOUND TO BE DAMAGED AND ENGAGED WITH THE DRIVE BAR. IT PREVENTED THE DEVICE FROM FIRING; HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. A BATCH/LOT RECORD REVIEW WAS PERFORMED AND THE BATCH MET ALL FINAL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL GASTRECTOMY PROCEDURE, THE DEVICE COULD NOT BE FIRED AT THE 2ND FIRING THOUGH THE DEVICE FUNCTIONED AS INTENDED AT THE 1ST FIRING. THE DEVICE WAS USED ON THE GASTRIC BODY. THE CARTRIDGE WAS GOLD. REINFORCEMENT MATERIAL WAS NOT USED. 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
    318215 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DG8Z

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60D(LOT#:UNK)X1