BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3941982 · Received July 17, 2014

    Report

    Report Number
    3005075853-2014-05053
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW MUCH BLOOD WAS LOST (ML)? - UNKNOWN. DID THE PATIENT REQUIRE A TRANSFUSION? - UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: CARTRIDGE. THE ANALYSIS FOUND THAT THE PSE60A DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH AN ECR60D CARTRIDGE RELOAD PRESENT; IT WAS NOTED TO BE FULLY FIRED. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS OF THE RELOAD IT WAS DISASSEMBLED AND THE RELOAD WAS NOTED TO HAVE THE CARTRIDGE DECK DAMAGED. THE DAMAGE TO THE CARTRIDGE IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT. IN ADDITION, THE KNIFE WAS INSPECTED UNDER MAGNIFICATION AND NICKS WERE FOUND. THE FOUND DAMAGE ON THE DECK AND KNIFE IS CONSISTENT WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE; WHEN THIS HAPPENS THE KNIFE PLOWS THE STAPLES ON CARTRIDGE DECK AND SHAVING MAY OCCUR. 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 TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND IT 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-FORM SHAPE. 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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BASED ON THE VISUAL EVIDENCE IN THE VIDEO, A CONDITION CALLED TISSUE PLOWING OCCURS. THIS TYPICALLY OCCURS WHEN CROSSING EXISTING STAPLE LINES OR WHEN THE KNIFE ENCOUNTERS A PRIOR FIRED STAPLE WHICH CAUSES THE KNIFE TO NOT COMPLETELY CUT THE TISSUE, BUT INSTEAD, PUSH AND/OR TEAR THE TISSUE. STAPLING OF MOVING TISSUE NORMALLY RESULTS IN MALFORMED STAPLES AND THE INABILITY TO MAINTAIN HEMOSTASIS. IN THE VIDEO, THE KNIFE STARTS PUSHING THE TISSUE TO THE DISTAL END AS SOON AS IT STARTS TO MOVE. THIS COULD BE INDICATIVE OF A DAMAGED KNIFE, BUT MOST LIKELY A STAPLE CAUGHT BY THE KNIFE. WHEN CROSSING AN EXISTING STAPLE LINE, THE CHANCES OF CATCHING A STAPLE CAN BE LESSENED IN TWO WAYS; MAKE SURE TO THOROUGHLY SWISH THE JAWS BETWEEN FIRINGS IN AN ATTEMPT TO CLEAR ANY STAPLES FROM THE JAWS AND, ATTEMPT TO CROSS STAPLE LINES BETWEEN 30 AND 60 DEGREES. CONCLUSION: BASED ON THE VIDEO EVIDENCE THE BELIEF IS THAT THE KNIFE ENCOUNTERED PREVIOUSLY FIRED STAPLES DURING ITS FORWARD PROGRESSION IN FIRING CAUSING THE TISSUE TO BE PUSHED OUT THE END OF THE DEVICE. HANDS ON ANALYSIS OF THE DEVICE AND CARTRIDGE MAY PROVIDE THE ADDITIONAL EVIDENCE NEEDED TO CONFIRM THIS CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE FOURTH FIRING, USING A GOLD RELOAD, AFTER +15 SECONDS OF COMPRESSION OF THE TISSUE THE BLADE SORT OF ¿SPIT¿ THE TISSUE TOWARDS THE DISTAL PART OF THE JAWS CAUSING BLEEDING AND STAPLE MALFORMATION. PRIOR TO THIS, THE SURGEON FIRED TWO GREEN RELOADS AND A GOLD RELOAD. AFTER THE FAILED FOUR FIRINGS WITH THE GOLD RELOAD, THE SURGEON FIRED A FIFTH GOLD RELOAD TO CORRECT THE FOURTH FIRING WITH THE SAME ENDOCUTTER. ALL FIRINGS EXCEPT FOR THE FOURTH ONE WORKED FINE. THE SURGEON IS A REGULAR USER OF DEVICE AND DIDN'T FEEL ANYTHING DIFFERENT WHEN USING THE ENDOCUTTER ON THIS CASE. THE SURGEON REINFORCED THE STAPLE LINE WITH SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418301 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60D