BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2143157 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02665
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 12, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE. THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A FULLY FIRED CARTRIDGE RELOAD PRESENT. THE CARTRIDGE WAS NOTED TO BE INDENTED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND IT FIRED, AND FORMED ALL THE STAPLES AS INTENDED. HOWEVER THE FIRING TRIGGER WAS NOT WORKING PROPERLY ON EACH STROKE AS THE PAWL WAS NOT ENGAGING WITH THE DRIVE BAR AT REPEATED ATTEMPTS. THE CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED KNIFE. THE DAMAGE TO THE CARTRIDGE DECK AND KNIFE IS CONSISTENT WITH THE DEVICE BEING 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 AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS AND WEAR WAS FOUND ON THE RIGHT SIDE OF THE CLOSURE TRIGGER DUE TO THE CLAMP FIRST LOCKOUT PIN ON THE GEARED TRIGGER PLATE. ONE POSSIBLE SCENARIO FOR THE DESCRIBED EVENT IS DUE TO APPLYING A LARGE PRYING FORCE ON THE CLOSURE TRIGGER HANDLE IN THE OPENING DIRECTION. THIS CAN THEN RESULT IN DAMAGE TO THE CLOSURE TRIGGER TOP COMPONENT IF THE APPLIED LOAD IS HIGH ENOUGH. ONCE THE CLOSURE TRIGGER TOP COMPONENT IS DAMAGED, THEN ANY ADDITIONAL ACTUATION OF THE FIRING TRIGGER CAN CAUSE IT TO RUB AGAINST THE NOW BROKEN OR BENT CLOSURE TRIGGER ASSEMBLY. 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 A GASTRIC PROCEDURE, WHEN TRYING TO CUT A STOMACH SECTION, THE DEVICE DID NOT CUT NOR STAPLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL FOLLOWUP: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? STOMACH. AT THE GASTROYEYUNOSTOMY. WHOLE MUCOSA ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4RV4W

    Patients

    Seq Age Sex Outcome Treatment
    1