BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 1972301 · Received January 28, 2011

    Report

    Report Number
    1527736-2011-00024
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).CARTRIDGE - ONE PIECE SLED. ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A BLUE CARTRIDGE PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED FROM THE RIGHT SIDE AND PARTIALLY FIRED FROM THE LEFT SIDE. UPON FURTHER INSPECTION, IT WAS NOTED THAT THE CARTRIDGE DECK AND ONE PIECE SLED WERE DAMAGE. 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. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED KNIFE. 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. 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, ON THE FIRST FIRING WITH A GOLD RELOAD, THE SURGEON COMMENTED THAT THE FIRING FELT WEIRD. AFTER REMOVING THE DEVICE, THEY FOUND ONE SIDE OF THE STAPLE LINE WAS OPEN. THE OPEN SIDE WAS THE SPECIMEN SIDE, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60D