BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON* 60 ENDOPATH**

    MDR report key: 2120986 · Received June 13, 2011

    Report

    Report Number
    3005075853-2011-02367
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 29, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE PIECE SLED. THE (B)(4) DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH A RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RECEIVED UNFIRED. UPON FURTHER INSPECTION OF THE RELOAD, THE ONE-PIECE SLED WAS FOUND DAMAGED. IMPROPER LOADING OF THE RELOAD MAY DAMAGE THE SLED. IF THE RELOAD IS NOT FULLY SEATED WHEN THE DEVICE IS CLOSED, THE SLED WILL BREAK. WHEN INSERTING THE RELOAD, SLIDE IT AGAINST THE BOTTOM OF THE RELOAD JAW UNTIL THE RELOAD ALIGNMENT TAB STOPS IN THE RELOAD ALIGNMENT SLOT. SNAP THE RELOAD SECURELY IN PLACE. THE INSTRUMENT IS NOW LOADED AND READY FOR USE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR THE COMPLETE GUIDE TO LOADING AND RELOADING THE INSTRUMENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES. HOWEVER, THE FIRING TRIGGER DID NOT RETURN TO ITS HOME POSITION AFTER EACH STROKE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE LEFT SIDE RELEASE BUTTON POST WAS NOTED TO BE BROKEN, THESE IS CONSISTENT WITH 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. ALTHOUGH THE RELEASE BUTTON IS NOT PART OF THE FIRING MECHANISM, WHEN IT BREAKS IT CREATES FRICTION TO THE FIRING MECHANISM NOT ALLOWING THE TRIGGER TO PROPERLY RETURN TO ITS HOME POSITION. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE 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 AN UNKNOWN PROCEDURE, THE DEVICE LOCKED OUT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER DETAILS OF THE EVENT ARE KNOWN. THERE WAS NO PATIENT IMPACT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON* 60 ENDOPATH** STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK F4MV76

    Patients

    Seq Age Sex Outcome Treatment
    1