BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3813633 · Received May 15, 2014

    Report

    Report Number
    3005075853-2014-03280
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 23, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED PAWL. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHEN THE DEVICE LOCKED UP, HAD IT BEEN FIRED? IF YES, WAS THE FIRING SEQUENCE COMPLETE? JUST FOR CLARIFICATION, AFTER MANUALLY UNLOCKED THE DEVICE WOULD NOT WORK. DOES THIS MEAN THE DEVICE COULD NOT BE FIRED? HOW WAS THE CASE COMPLETED? NO ADDITIONAL INFORMATION WAS PROVIDED. THE ANALYSIS FOUND THAT ONE PSE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE LOADED ON THE DEVICE. 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 SUBSEQUENT 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 THEN, THE KNIFE ONLY ADVANCED FEW MILLIMETERS AND THE FIRING STOPPED. THE KNIFE REVERSE BUTTON WAS ACTIVATED AND THE KNIFE RETURNED TO HOME AS INTENDED. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE PAWL BAILOUT WAS FOUND TO BE DAMAGED AND ENGAGED WITH THE DRIVE BAR. IT PREVENTED THE DEVICE FROM FIRING; HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. 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 BYPASS PROCEDURE, THE DEVICE LOCKED UP. HAD TO MANUALLY UNLOCK AND THEN IT WOULD NOT WORK. THERE WERE NO PATIENT CONSEQUENCES. UNKNOWN HOW CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291124 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1