BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 1873493 · Received October 19, 2010

    Report

    Report Number
    3005075853-2010-05926
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 24, 2010
    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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE EC60 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A FULLY FIRED RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED; HOWEVER, THE CUT WAS JAGGED DUE TO A DAMAGED KNIFE. ONE POSSIBLE CAUSE FOR THE DAMAGED KNIFE MAY BE IF 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, 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. IT IS ALSO RECOMMENDED THAT 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. 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. HAD THE SURGEON NOT LEFT SOME SAFETY MARGIN (AS IS THE CASE FOR WHILE OPERATING PATIENTS WITH HIGHER BMI ON WHOM A TIGHTER SLEEVE IS ATTEMPTED FOR INCREASED WEIGHT LOSS) THE ECHELON MALFUNCTIONING COULD HAVE RESULTED IN COMPLETE GASTRIC BYPASS. THE SURGEON HAS ALSO SENT THE GREEN CARTRIDGE USED FOR FIRING FOR ANALYSIS AS THIS IS THE FIRST TIME HE HAD HEARD / SEEN AN INCOHERENT AND STAGGERED STAPLE RELEASE. THE CARTRIDGE SHOWS THAT ONLY THE STAPLES FROM PROXIMAL 1/3RD AND DISTAL 1/3RD OF STAPLE LENGTH WERE RELEASED. THE MIDDLE 1/3RD WAS COMPLETELY MISSED. THIS DEFIES THE STANDARD STAPLING MECHANISM OF ECHELON STAPLER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, A GREEN CARTRIDGE WAS USED TO PERFORM THE FIRST FIRING. AFTER THE FIRST FIRING, THE FIRING TRIGGER BECAME COMPLETELY LOOSE AND DID NOT GIVE ANY TACTILE FEEDBACK. NO AUDITORY FEEDBACK WAS RECEIVED DURING THE FIRING, AS IS THE CASE NORMALLY. THE SURGEON TRIED TO PULL THE FIRING TRIGGER A FEW MORE TIMES, BUT STILL GOT NO TACTILE RESPONSE OR AUDITORY FEEDBACK. THE SURGEON THEN TRIED TO OPEN THE DEVICE BY PULLING THE RELEASE LEVER AND FAILED. THE KNIFE BLADE DID NOT RETRACT EVEN AFTER PULLING THE MANUAL RELEASE LEVER. AFTER A LOT OF ATTEMPTS, THE DEVICE OPENED. THE GASTRIC TISSUE WAS COMPLETELY CRUSHED FOR THE DISTAL 2/3RD STAPLE LENGTH. NO STAPLES WERE FORMED AFTER THE PROXIMAL 1/3RD STAPLE LENGTH. THE SURGEON HAD FORTUNATELY LEFT SOME SAFETY MARGIN FOR THE FIRING, WHICH HELPED HIM ATTEMPT A SECOND FIRING. THIS RESULTED IN FORMATION OF TIGHTER SLEEVE THAN THE SURGEON HAD INTENDED. PLEASE NOTE THAT ONLY THE PROXIMAL 1/3RD STAPLES WERE FORMED ON THE GASTRIC TISSUE. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1