BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4090279 · Received September 15, 2014

    Report

    Report Number
    3005075853-2014-06425
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 29, 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). ADDITIONAL INFORMATION: 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 ECR60G 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 BAILOUT SYSTEM AND THEN, IT 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. THE EVENT COULD NOT BE CONFIRMED AS NO MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). : INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE DEVICE DELIVER ANY STAPLES? YES, THE KNIFE SLIGHTLY MOVED FORWARD AND A FEW STAPLES OF PROXIMAL END WERE DEPLOYED. IF YES, WERE THE STAPLES FORMED PROPERLY? NO. IF YES, WAS THE STAPLE LINE COMPLETE? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN LOW ANTERIOR RESECTION, THE DEVICE COULD BE FIRED WITHOUT PROBLEM AT THE 1ST FIRING. HOWEVER, THE KNIFE STOPPED AT THE 2ND FIRING AFTER MOVING A FEW MILLIMETERS AND THEN IT DID NOT MOVE FORWARD THOUGH THE FIRING TRIGGER WAS GRASPED SEVERAL TIMES. THE KNIFE OF THE DEVICE WAS RETURNED WITH THE KNIFE REVERSE SWITCH. THE DEVICE WAS USED ON THE RECTUM. AS THERE WAS THE MESORECTUM, THE TARGET TISSUE WAS THICK. EVENTUALLY, A COMPETITOR'S DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AFTER THIS INCIDENT, WHEN THE SALES REP FIRED THE DEVICE, IT FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568883 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELAOD - ECR60G (LOT # L4EA6U)