BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2211324 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03290
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 21, 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
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT THE EC60A DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH TWO ECR60D RELOADS PRESENT. THE RELOADS WERE RECEIVED FULLY FIRED. 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. THE CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED 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 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. 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. 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

    FIELD QUALITY ENGINEER REVIEWED THE VIDEO FOR RECEIVED. OBSERVATIONS: IN GENERAL IT IS MY OPINION THAT A CARTRIDGE SELECTION OF GOLD FOR THIS THICKNESS/DENSITY OF TISSUE LEFT NO MARGIN FOR ANY OTHER CHALLENGES. THE FIRST FIRING WITH THE GOLD CARTRIDGE AT 0:05 WAS SUCCESSFUL. A CROTCH STAPLE WAS IDENTIFIED AND REMOVED PRIOR TO THE 3ND FIRING. THE DEVICE WAS PLACED AND CLAMPED AT APPROXIMATELY 0:49 INTO THE VIDEO. THE DEVICE WAS UNCLAMPED REPOSITIONED AND THEN RECLAMPED AT APPROXIMATELY 1:27. DEVICE FIRING STARTED AT APPROXIMATELY 1:42 WITH VERY RAPID FIRING STROKES. THE TISSUE COULD BE OBSERVED MOVING/BEING PLOWED FORWARD WITHIN THE JAWS ALMOST IMMEDIATELY. THE TISSUE STOPPED MOVING AT APPROXIMATELT THE 20MM MARK ON THE CARTRIDGE CHANNEL. (REFERENCE VISUAL AT 1:47). THIS TYPE OF TISSUE MOVEMENT TYPICALLY WILL OCCUR WHEN THE FORCES GENERATED BY THE KNIFE TRYING TO CUT THROUGH THICK TISSUE AND/OR A HARD OBJECT EXCEED THE TISSUE RETENTION FORCE OF THE JAWS. CONCLUSION: IN MY OPINION THAT BORDERLINE CARTRIDGE SIZE SELECTION, FIRING ACROSS THE PREVIOUSLY LAYED STAPLE LINE AND RAPID FIRING ALL COMBINED TO CAUSE TISSUE PLOWING WHICH LED TO A INCOMPLETE CUT LINE AND MALFORMED STAPLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE HEALTH CARE PROFESSIONAL WAS IN SURGERY CREATING THE STOMACH POUCH, THE FIRST TRANSVERSAL SHOOT WAS OK. WHEN THE SURGEON STARTED TO GO UP TO THE FUNDUS AND USED A GOLD CARTRIDGE, THE SURGEON FIRED FOUR TIMES THE DEVICE, FINISHED THE STAPLING AND OPENED THE STAPLER, BUT THE KNIFE DIDN'T CUT ALL THE WAY AND THE STAPLES WERE MALFORMED. THE SURGEON TRIED TO CORRECT THIS USING ANOTHER GOLD CARTRIDGE TO STAPLE JUST BESIDE THE FIRST ATTEMPT BUT IT WAS USELESS. THE HEALTH CARE PROFESSIONAL TRIED TO STAPLE THE TISSUE ON ONE SIDE SO HE COULD MAKE THE STOMACH POUCH. THE SURGEON HAD TO USE MANUAL SUTURE AND THE SURGEON CHOSE TO OPEN A NEW FLEX FOR THE REST OF THE PROCEDURE BECAUSE THE TISSUE WAS VERY MUCH DAMAGED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43T7E

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR RELOAD-ECR60D