BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3973615 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05417
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 15, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) = CARTRIDGE, ONE PIECE SLED. THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60W PARTIALLY FIRED 1/16 LOADED ON 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. UPON EVALUATION, THE RELOAD WAS NOTED TO HAVE THE RETENTION FEATURES DAMAGED AS IF IT WAS LOADED INCORRECTLY. IT IS POSSIBLE THAT THE TABS WERE DAMAGED DUE TO AN IMPROPER LOADING TECHNIQUE. PLEASE NOTE THAT TO INSERT A NEW RELOAD, SLIDE IT AGAINST THE BOTTOM OF THE CARTRIDGE JAW UNTIL THE CARTRIDGE ALIGNMENT TAB STOPS IN THE RELOAD ALIGNMENT SLOT. SNAP THE RELOAD SECURELY IN PLACE. REMOVE THE STAPLE RETAINING CAP AND DISCARD. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE AND THE RETURNED RELOAD AND THEY ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINES AND CUT LINES WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. IT SHOULD BE NOTED THAT THE BATTERY PACK HAS A DRAIN FEATURE THAT DRAINS THE PACK WITHIN 24 HOURS OF THE PROCEDURE; THEREFORE TESTING CANNOT BE COMPLETED ON THE ORIGINAL BATTERY USED IN THE PROCEDURE. AS A RESULT, PRODUCT INQUIRIES ARE TESTED WITH NON-DRAINING PACKS/SIMULATORS. 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 GASTRIC SLEEVE PROCEDURE, THE SURGEON SAYS THAT DEVICE STAPLED FINE ON FIRST TWO STAPLE LINES AND THEN IT APPEARED THAT THE BATTERY DIED IN THE MIDDLE OF FIRING THIRD STAPLE LINE. STAPLER WAS REMOVED AND NEW STAPLER OPENED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450113 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1