BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 ARTICULATING

    MDR report key: 2213959 · Received August 17, 2011

    Report

    Report Number
    3005075853-2011-03338
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): CARTRIDGE. ONE EC45A DEVICE WAS RETURNED IN GOOD VISUAL CONDITIONS AND WITH A WHITE CARTRIDGE PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED. IN ADDITION THE DEVICE WAS NOTED TO BE CLAMPED ON A METAL OBJECT. UPON FURTHER INSPECTION, IT WAS NOTED THAT THE CARTRIDGE DECK WAS DAMAGED AND THE ONE PIECE SLED WAS SPLIT IN HALF. THIS DAMAGE IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT. WHEN THIS HAPPENS THE CARTRIDGE GETS INDENTED THEREFORE THERE IS NOT ENOUGH SPACE FOR THE SLED PUSHING THE DRIVER TO CONTINUE ITS RUN, THIS IS THE REASON WHY THE SLED GETS DAMAGED. WHEN PLACING THE INSTRUMENT ON THE TISSUE TO BE STAPLED, ENSURE THAT NO HARD OBSTRUCTION (SUCH AS A CLIP) IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR WARNINGS AND PRECAUTION REGARDING FIRING ACROSS HARD OBJECTS. A REVERSE STROKE WAS PERFORMED ON THE DEVICE TO RETURN THE KNIFE TO THE HOME POSITION. PLEASE NOTE THAT A HIGH LOAD HAD TO BE APPLIED TO THE TRIGGER TO UN-JAM THE FIRING MECHANISM DUE TO THE METAL OBJECT IN THE JAWS. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITIONS WITH TEST CARTRIDGE RELOADS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TOTAL VAGINAL HYSTERECTOMY PROCEDURE THE SURGEON FIRED THE DEVICE OVER A HULKA CLIP AND THE DEVICE PARTIAL FIRED AND LOCKED OUT AT THE BEGINNING OF THE THIRD FIRING STROKE. THE SURGEON TRIED TO OPEN THE DEVICE AND THE DEVICE WOULD NOT OPEN. THEY CLAMPED THE AREA AND THE DEVICE WAS CUT OFF TISSUE. THE CASE WAS COMPLETED WITH CUT, CLAMP AND TIE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1