BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3973719 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05428
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 6, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE EC45A DEVICE WAS RETURNED WITH THE CLAMPING MECHANISM DAMAGED AND WITHOUT RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. HOWEVER, THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS AND THE YOKE WAS NOTED TO BE BROKEN. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE YOKE BECAME BROKEN, THIS DAMAGE CAN OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE CLOSING TRIGGER WHEN THE JAWS ARE CLAMPED OVER AN EXCESS OF TISSUE. UPON FURTHER INSPECTION, THE JOINT COVER WAS NOTED TO BE TORN; THERE IS NO EVIDENCE THAT THERE IS ANY PORTION OF THE JOINT COVER MISSING. IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO BE PULLED OUT FROM A TROCAR IN THE ARTICULATED POSITION, RESULTING IN THE EDGE OF THE TROCAR DAMAGING THE JOINT COVER. THE REPORTED EVENT COULD NOT BE CONFIRMED AS NO CUTTING ISSUES WERE NOTED DURING FUNCTIONAL TESTING. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CYSTECTOMY PROCEDURE, THE DEVICE WOULD NOT CUT THROUGH THE TISSUE AFTER THE SIXTH RELOAD. 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
    449927 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DM2U

    Patients

    Seq Age Sex Outcome Treatment
    1