BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3961794 · Received July 28, 2014

    Report

    Report Number
    3005075853-2014-05267
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: CARTRIDGE, ONE PIECE SLED, DRIVERS. THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION, WITH THE CLOSING TRIGGER AND ANVIL IN THE CLOSED POSITION, WITH THE KNIFE NOT FULLY BACK. FURTHERMORE, A DRIVER WAS FOUND LODGED BEHIND THE KNIFE, RESULTING IN THE FIRING MECHANISMS JAMMING. IN ADDITION, AN ECR60D CARTRIDGE RELOAD WAS RECEIVED LOADED IN THE DEVICE, DAMAGED AND WITH THE RIGHT SIDE FULLY FIRED, LEFT SIDE PARTIALLY FIRED 1/16. FURTHERMORE, THE CARTRIDGE PAN WAS BENT AND DAMAGED AT PROXIMAL END WITH ONE DOUBLE DRIVER OUT OF POSITION. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. UPON REMOVAL OF THE JAMMED DRIVER THE KNIFE WAS FULLY RETURNED BY COMPLETING THE RETURN STROKE AND THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD. THE DEVICE ACHIEVED ITS COMPLETE 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE SURGEON PLACED THE DEVICE (WITH A GOLD RELOAD) ON THE RECTOSIGMOID PORTION AND FIRED. AFTER FOUR STROKES FIRING CYCLE, THE JAWS DIDN¿T OPEN. THE STROKE COUNTER INDICATOR WAS EMPTY AND DIDN¿T SHOW LOCK OUT SIGN OR THE NUMBER OF STROKES. THE SURGEON PUSHED THE MANUAL KNIFE REVERSE SWITCH AND SQUEEZED THE FIRING TRIGGER AGAIN ¿ THE KNIFE, WHICH WAS STUCK AT THE PROXIMAL THIRD, DIDN¿T MOVE AND STILL THE JAWS DIDN¿T OPEN. THE SURGEON CLAMPED THE TISSUE AND RESECTED IT IN ORDER TO RELEASE IT AND TAKE THE DEVICE OUT OF THE BODY. THE SURGEON COMPLETED THE PROCEDURE LAPAROSCOPICALLY WITH ANOTHER STAPLER. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439119 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E98T

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60D