BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON* 60 ENDOPATH STAPLER

    MDR report key: 3931340 · Received July 14, 2014

    Report

    Report Number
    3005075853-2014-04896
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 2, 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
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED FIRING SHUTTLE. THE ANALYSIS RESULTS FOUND THAT ONE LONG60 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD PRESENT. THE DEVICE WAS NOTED TO HAVE THE FIRING MECHANISM DAMAGED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING SHUTTLE SPRING WAS FOUND DAMAGED, NOT ALLOWING THE FIRING MECHANISM TO PROPERLY FUNCTION. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE FIRING SHUTTLE SPRING BECAME DAMAGED; IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4) . 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, DURING THE FIRST FIRE WITH BLACK CARTRIDGE, THE HANDLE MADE STRANGE NOISE (LIKE SOMETHING BROKE) AND THE HANDLE GOT LOOSE (MOVING FREE WITHOUT MOVING THE KNIFE / STAPLE DRIVER). THE SURGEON USED THE MANUAL LEVER TO OPEN THE JAWS AND SAW 1 CM STAPLE LINE. HE PUT A NEW CARTRIDGE IN AND THE SAME HAPPENED AGAIN. HE SWITCHED THE ECHELON DEVICE, PUT A NEW BLACK CARTRIDGE AND ACHIEVES A FULL FIRE CYCLE (THREE STROKES) BUT HE CLAIMED HE USED EXTRA POWER TO SQUEEZE THE HANDLES. AFTER THE CYCLE HE TRIED TO OPEN THE JAWS BUT THEY OPENED ONLY 50% OF THEIR APERTURE. HE TOOK ANOTHER ECHELON DEVICE AND COMPLETED THE PROCEDURE WITHOUT ANY OTHER PROBLEMS. SURGERY WAS PROLONGED TEN MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409184 ECHELON* 60 ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DK6E

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60T