BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 1811609 · Received August 23, 2010

    Report

    Report Number
    3005075853-2010-04788
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    March 22, 2010
    Report Date
    March 26, 2010
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT A: INCOMPLETE/INTERRUPTED FIRING CYCLE. INSTRUMENT B: CLOSURE TRIGGER TOP. THE ANALYSIS FOUND THAT ONE LONG60A DEVICE A WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60D PARTIALLY FIRED RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT AND ARTICULATED POSITIONS USING TEST CARTRIDGE RELOADS AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B. THE ANALYSIS FOUND THAT ONE LONG60A DEVICE B WAS RETURNED IN GOOD VISUAL CONDITION AND WITH BLUE CARTRIDGE RELOAD PRESENT. THE CARTRIDGE WAS RECEIVED PARTIALLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT AND ARTICULATED POSITIONS WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. HOWEVER THE FIRING TRIGGER WAS NOT WORKING PROPERLY ON EACH STROKE AS THE PAWL WAS NOT ENGAGING WITH THE DRIVE BAR AT REPEATED ATTEMPTS. ADDITIONALLY, THE CUT WAS NOTED TO BE JAGGED DUE TO A NICKED KNIFE. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE TO THE KNIFE IS WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECTS, 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. ADDITIONALLY, 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 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 PULLING THE CLOSURE TRIGGER OPEN IN AN ATTEMPT TO OPEN THE DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC SLEEVE PROCEDURE ON THE FIRST FIRING OF THE GASTRIC SLEEVE WITH A GREEN LOAD USING PERI STRIPS THE DEVICE WAS PLACED ON A STOMACH. THE DEVICE WOULD NOT FIRE ON THE SECOND FIRING STROKE OF THE FIRST FIRING. THE SURGEON PUSHED THE KNIFE REVERSE AND FINISHED THE FIRING STROKE AND REMOVED THE DEVICE FROM TISSUE. THE SURGEON CUT THE PERI STRIPS OFF THAT WERE HANGING THERE AND PULLED ANOTHER DEVICE. THE SECOND DEVICE FIRED FINE FIVE DIFFERENT TIMES WITH TWO GOLD AND THREE BLUE RELOADS USING PERI STRIPS. ON THE SIXTH FIRING WITH A BLUE LOAD THE DEVICE WOULD NOT FIRE ON THE SECOND FIRING STROKE. THE SURGEON PUSHED THE KNIFE REVERSE AND FINISHED THE FIRING STROKES AND REMOVED THE DEVICE FROM TISSUE. PERI STRIPES WERE CUT AND A THIRD DEVICE WAS PULLED. THE THIRD DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4RN37

    Patients

    Seq Age Sex Outcome Treatment
    1