BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3932249 · Received July 14, 2014

    Report

    Report Number
    3005075853-2014-04916
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 13, 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)(6)- DAMAGED RELEASE BUTTON. THE ANALYSIS FOUND THAT ONE PSE60A DEVICE WAS RECEIVED FOR ANALYSIS WITHOUT CARTRIDGE RELOAD. THE MANUAL OVERRIDE DOOR WAS NOTED TO BE OUT OF POSITION AND MISSING; THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. PLEASE NOTE IF THE INSTRUMENT IS PARTIALLY FIRED, SLIDE THE KNIFE REVERSE SWITCH FORWARD TO RETURN THE KNIFE 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. 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. 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 A LAP LOW ANTERIOR RESECTION, A NURSE GRASPED THE CLOSING LEVER FOR CHECKING IF THE CARTRIDGE WAS LOADED PROPERLY BEFORE THE 1ST FIRING. THEN, THE RELEASE BUTTON WAS MOVED FORWARD BUT THE ANVIL DID NOT OPEN THOUGH THE CLOSING LEVER RETURNED TO THE HOME POSITION. THE DOCTOR MOVED THE RELEASE BUTTON AND THE CLOSING LEVER SEVERAL TIMES BUT THE ANVIL DID NOT OPEN. EVENTUALLY, THE ANVIL OPENED WITH THE MANUAL OVERRIDE. AFTER THAT, THE DEVICE COULD NOT BE CLOSED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410871 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EH7V

    Patients

    Seq Age Sex Outcome Treatment
    1