BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 1904472 · Received November 22, 2010

    Report

    Report Number
    1527736-2010-00102
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    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) RELEASE BUTTON THE ANALYSIS FOUND THAT ONE (B)(4) DEVICE WAS RETURNED WITH ONE (B)(4) CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. IN ADDITION, A XCEL 12 MM TROCAR WAS RECEIVED ON THE DEVICE. THE DEVICE WAS RECEIVED WITH THE ANVIL CLOSED AND WITH THE INDICATOR IN THE LOCK POSITION. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE WITH THE INDICATOR IN THE LOCKED POSITION A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. ONCE THE DEVICE IS OPENED THE DEVICE CAN BE DE-ARTICULATED. AFTER FURTHER ANALYSIS THE CLAMPING MECHANISM WAS NOTED TO BE 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 RELEASE BUTTON WAS FOUND BROKEN MOST PROBABLY DO TO ATTEMPTING TO OPEN THE LOCKED DEVICE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LEFT COLECTOMY PROCEDURE, THE DEVICE LOCKED ON BOWEL AND WAS DIFFICULT TO REMOVE DESPITE USING THE RELEASE BUTTON AFTER SEVERAL ATTEMPTS. THERE WAS FORCE USED TO REMOVE THE DEVICE. THERE WAS NO TISSUE DAMAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA G4TA2V

    Patients

    Seq Age Sex Outcome Treatment
    1