BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2211439 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03295
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE PIECE SLED. ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60D CARTRIDGE PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED ON THE LEFT SIDE AND PARTIALLY FIRED ON THE RIGHT SIDE; IN ADDITION, IT WAS NOTED THAT THE CARTRIDGE DECK AND ONE PIECE SLED WERE DAMAGED. 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. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT AND 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR RESECTION PROCEDURE, THE SURGEON, AN EXPERIENCED USER, WAS SUPERVISING HIS RESIDENT FIRING THE DEVICE ACROSS THE BOWEL. THEY REPORT THAT THE FIRING WAS EXTREMELY DIFFICULT AND THE RESIDENT WAS FORCED TO FIRE WITH TWO HANDS. AT THE END OF THE FIRING THE STAPLES WERE LARGELY UNFORMED. THE STAPLE LINE HAD SPLIT APART AND MOST STAPLES WERE NOT FORMED AT ALL. THE TISSUE WAS NOT PARTICULARLY THICK AND IN FACT THEY TOOK ANOTHER FLEX 60MM AND SUCCESSFULLY TRANSECTED BELOW THE FAILED FIRING. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43H5E

    Patients

    Seq Age Sex Outcome Treatment
    1