BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3972745 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05389
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4) - CARTRIDGE, DRIVERS, ONE PIECE SLED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PER THE SALES REP: BMI IS 54.8 CONCLUSION: BASED ON THE PHOTOGRAPHIC EVIDENCE OF THE SUBJECT LONG60A DEVICE AND ECR60G CARTRIDGE, THE EVENT DESCRIPTION CAN BE CONFIRMED, HOWEVER, THE PHOTOGRAPHS DO NOT PROVIDE EVIDENCE RELATIVE TO WHAT MAY HAVE CAUSED THE ISSUE. HANDS ON ANALYSIS OF THE DEVICE AND CARTRIDGE MAY PROVIDE THE ADDITIONAL EVIDENCE NEEDED TO DETERMINE THE CAUSE OF THE COMPLICATION. THE HANDS-ON ANALYSIS FOUND THAT ONE LONG60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60G RELOAD PRESENT. THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, LEFT SIDE OUTER ROW FULLY FIRED AND THE LEFT TWO INNER ROWS PARTIALLY FIRED 1/6. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. AS ADDITIONAL TESTING, THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, ON THE THIRD FIRING (GREEN RELOAD) WITH GORE® SEAM GUARD THE FIRING FELT DIFFERENT, A LITTLE HARDER TO FIRE. ON THE PATIENT¿S SIDE (SLEEVE SIDE) THE TWO INNER ROWS NO DEPLOYED; BUT THERE WERE A FEW STAPLES IN THE TISSUE THAT WERE ¿GOAL POST¿ IN SHAPE. THE OUTER MOST ROW WAS DEPLOYED AND THE STAPLES WERE MALFORMED. THE REMNANT SIDE WAS FINE. A SECOND DEVICE WAS OPENED AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. THE FIRST FIRING THE SURGEON USED A BLACK CARTRIDGE. THE SECOND FIRING THE SURGEON USED A GREEN RELOAD. BMI IS UNKNOWN (MALE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450558 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA LN177M

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60G LOT: L4ER39