BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4203188 · Received October 27, 2014

    Report

    Report Number
    3005075853-2014-07381
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = LINK PIN, CLOSING TRIGGER. THE LONG60 DEVICE WAS RECEIVED FOR ANALYSIS WITH THE CLAMPING MECHANISM DAMAGED AND WITH NO CARTRIDGE RELOAD PRESENT. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND THE CLOSURE LINK WAS FOUND BROKEN IN THE AREA WHERE IT LATCHES WITH CLOSURE TRIGGER. FURTHERMORE THE CLOSURE LINK PIN WAS OUT OF POSITION AND MISSING. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE CLOSURE LINK BECAME DAMAGED AND THE CLOSURE LINK PIN TO BE OUT OF POSITION AND MISSING, IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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 AN UNKNOWN PROCEDURE, THE DEVICE DIDN'T CLOSE WHEN THE TISSUE WAS LOADED INTO THE JAW. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684713 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DG9N

    Patients

    Seq Age Sex Outcome Treatment
    1