BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3944229 · Received July 18, 2014

    Report

    Report Number
    3005075853-2014-05089
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD PRESENT. THE MANUAL OVERRIDE DOOR WAS NOTED TO BE OUT OF POSITION; 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. 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 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. ONCE THE DEVICE COMPLETED THE FIRING SEQUENCE THE KNIFE RETURNED HOME AS INTENDED. THE KNIFE REVERSE BUTTON WORKED PROPERLY DURING TESTING. IT SHOULD BE NOTED THAT TO OPEN THE JAWS, SQUEEZE THE CLOSING TRIGGER, AND THEN SIMULTANEOUSLY PRESS THE ANVIL RELEASE SWITCH ON EITHER SIDE OF THE INSTRUMENT. WHILE PRESSURE IS STILL ON THE ANVIL RELEASE SWITCH, SLOWLY RELEASE THE CLOSING TRIGGER. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, ON THE THIRD FIRING ON THE STOMACH, THE KNIFE BLADE WOULD NOT RETURN AFTER FIRING. THE SURGEON TROUBLESHOOTED WITH THE REP - HIT THE REVERSE BUTTON, CHECKED BATTERY, HIT THE REVERSE BUTTON, AND HAD TO RESORT TO THE MANUAL OVERRIDE. THE FIRST FIRING WAS WITH A BLACK RELOAD NO BUTTRESS, SECOND FIRING WAS WITH A BLACK RELOAD AND GORE BUTTRESS (FOR ANOTHER STAPLER). THIRD FIRE WAS A BLACK RELOAD WITH GORE BUTTRESS (FOR A ANOTHER STAPLER). CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422587 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E520

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60T