BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4013689 · Received August 15, 2014

    Report

    Report Number
    3005075853-2014-05752
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Report Date
    July 1, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RELEASE BUTTON. THE ANALYSIS FOUND THAT ONE PSE45A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR45W CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. FURTHERMORE, THE DEVICE WAS FOUND TO HAVE THE CLAMPING MECHANISM DAMAGED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE CLAMP ARM RELEASE AND RELEASE BUTTON WERE NOTED WORN AND DAMAGED IN THE AREA WHERE BOTH INTERACT. THIS DAMAGE SUGGESTS THE DEVICE WAS FORCED TO OPEN WITH THE KNIFE NOT IN THE HOME POSITION BY PULLING THE CLOSING TRIGGER TO HOME. 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. NO FURTHER FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. HOWEVER, A DRY FIRE WAS PERFORMED AND THE FIRING MECHANISM WORKED AS INTENDED. 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 WOULD NOT OPEN ALL THE WAY AND IT WOULD NOT LOCK. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489871 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L90G60

    Patients

    Seq Age Sex Outcome Treatment
    1