BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION TRIPLE LUMEN SPHINCTEROTOME

    MDR report key: 5701710 · Received June 6, 2016

    Report

    Report Number
    1037905-2016-00168
    Event Type
    Malfunction
    Date Received
    June 6, 2016
    Date of Event
    May 12, 2016
    Report Date
    May 12, 2016
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    00827002315334
    PMA / PMN Number
    K033203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES; COOK FUSION WIRE GUIDE (FSW-35); ERBE ELECTROSURGICAL GENERATOR. INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT OF INCORRECT CUTTING WIRE ORIENTATION. DURING THE LABORATORY ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2 MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 2 O'CLOCK. THE DEVICE WAS THEN BOWED AND THE CUTTING WIRE WAS FACING 2 O'CLOCK (APPROPRIATE ORIENTATION IS APPROXIMATELY 11:00 - 1:00 O'CLOCK). PRIOR TO FUNCTIONAL TESTING, THE SPHINCTEROTOME CATHETER WAS SUBJECTED TO A CLOSE VISUAL EXAMINATION AT THE DISTAL END AS IT LAID FLAT, AND TWISTING OF THE TUBING WAS NOT OBSERVED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS OBSERVATION WAS NOT FOUND DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. IMPROPER CUTTING WIRE ORIENTATION CAN OCCUR IF THE DISTAL END OF THE CATHETER IS SHAPED MANUALLY. THIS SPHINCTEROTOME CATHETER IS PRE-CURVED AND IS PROVIDED WITH A PRE-CURVED STYLET IN THE DISTAL TIP OF THE CATHETER. THIS OBVIATES THE NEED FOR MANUAL FORMATION. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: ¿NOTE: DO NOT APPLY MANUAL PRESSURE TO TIP OR CUTTING WIRE OF SPHINCTEROTOME TO INFLUENCE ORIENTATION, AS THIS MAY RESULT IN DAMAGE TO DEVICE.¿ OTHER FACTORS THAT CAN CONTRIBUTE TO IMPROPER CUTTING WIRE ORIENTATION INCLUDE MANIPULATING THE HANDLE WITH THE CATHETER IN A COILED POSITION OR WITH THE PRECURVED STYLET INSIDE THE CANNULATING TIP. THE INSTRUCTIONS FOR USE ADVISE THE USER TO UNCOIL AND STRAIGHTEN THE SPHINCTEROTOME UPON REMOVING THE DEVICE FROM THE PACKAGING. THE USER IS THEN INSTRUCTED TO "CAREFULLY REMOVE THE PRECURVED STYLET FROM THE CANNULATING TIP". THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT EXERCISE HANDLE WHILE DEVICE IS COILED OR PRECURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE TO SPHINCTEROTOME AND RENDER IT INOPERABLE." PRIOR TO DISTRIBUTION, ALL FUSION TRIPLE LUMEN SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME. THE PHYSICIAN REPORTED THAT THERE WAS POOR ORIENTATION. THE CANNULA WAS INTRODUCED AND EXITED THE WORKING CHANNEL OF THE ENDOSCOPE IN A 2 O'CLOCK POSITION, INCREASING THE DIFFICULTY OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354573 FUSION TRIPLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY 00827002315334

    Patients

    Seq Age Sex Outcome Treatment
    1