BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 1890634 · Received November 2, 2010

    Report

    Report Number
    3005075853-2010-06231
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 7, 2010
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RELEASE BUTTON THE ANALYSIS FOUND THAT ONE (B)(4) DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH NO CARTRIDGE PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. HOWEVER, THE FIRING TRIGGER DID NOT RETURN TO ITS HOME POSITION AFTER EACH STROKE. THE CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED KNIFE. THE DEVICE OPENED AND CLOSED WITHOUT DIFFICULTIES. ONE POSSIBLE CAUSE FOR THE DAMAGED KNIFE MAY BE IF THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. REPEATEDLY FIRING ACROSS EXISTING STAPLE LINES CAN ALSO REDUCE THE ABILITY TO CUT CLEANLY. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE RELEASE BUTTON WAS NOTED TO BE DAMAGED. ALTHOUGH THE RELEASE BUTTON IS NOT PART OF THE FIRING MECHANISM, WHEN IT BREAKS IT CREATES FRICTION TO THE FIRING MECHANISM RESULTING IN THE TRIGGER NOT PROPERLY RETURNING TO ITS HOME POSITION. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE MAY BE PARTIALLY ENGAGING THE ANVIL RELEASE BUTTON INADVERTENTLY AFTER CLOSING THE DEVICE BUT BEFORE FIRING. THIS CAUSES THE RELEASE BUTTON TO PARTIALLY ENGAGE WITH THE INDICATOR GEAR. AS A RESULT OF THIS CONDITION, WHEN ATTEMPTING TO FIRE, SIGNIFICANT RESISTANCE WILL BE FELT DUE TO THE FACT THAT THE RELEASE BUTTON IS BLOCKING THE PATH OF THE INDICATOR GEAR. IF THE FIRING STROKE IS CONTINUED PAST THIS POINT, THE INDICATOR GEAR PUSHES INTO ON THE RELEASE BUTTON, RESULTING IN DAMAGE OR BREAKAGE OF THE RELEASE BUTTON. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 11/02/2010. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE WOULD NOT OPEN. JUST AFTER THE PASSAGE OF THE TROCAR AND BEFORE THE SURGEON PUT THE STAPLER, THE JAWS DID NOT OPEN. THE SURGEON USED A NEW STAPLER. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4RH5V

    Patients

    Seq Age Sex Outcome Treatment
    1