BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    FUSION OMNI-TOME

    MDR report key: 5794009 · Received July 14, 2016

    Report

    Report Number
    1037905-2016-00220
    Event Type
    Malfunction
    Date Received
    July 14, 2016
    Report Date
    March 7, 2016
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    00827002319035
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER EXEMPTION NUMBER: E2015051. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM. ADDITIONAL LOT NUMBERS: W3657913, W3668230, W3671457, W3678109, W3681043, W3685625, W3690377. ONE (1) UNKNOWN LOT NUMBER. CONTINUED FROM SECTION D.11. BOSTON SCIENTIFIC JAGWIRE WIRE GUIDE, UNKNOWN MODEL. ERBE ELECTROSURGICAL GENERATOR, UNKNOWN MODEL. SYRINGE, UNKNOWN MAKE OR MODEL. ENDOSCOPE, UNKNOWN MAKE OR MODEL. COOK TRACER METRO WIRE GUIDE (MET-25-480). PENTAX DUODENOSCOPE, UNKNOWN MODEL. OLYMPUS TJFT260V ENDOSCOPE. COOK FUSION WIRE GUIDE (FSW-35). WIRE GUIDE, UNKNOWN MAKE OR MODEL. CONTINUED FROM H.6. EC METHOD CODES: (B)(4). SEVENTEEN (17) REPORTED DEVICES, TWELVE (12) DEVICES WERE RETURNED TO COOK ENDOSCOPY FOR EVALUATION. OUR EVALUATION OF EIGHT (8) OF THE RETURNED DEVICES CONFIRMED THE REPORT OF INCORRECT CUTTING WIRE ORIENTATION. DURING OUR LABORATORY ANALYSIS, THE SPHINCTEROTOMES WERE EACH 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 CATHETERS EXITED THE ENDOSCOPE WITH THE CUTTING WIRES FACING IN THE RANGE OF 2 O¿CLOCK TO 11 O'CLOCK. THE DEVICES WERE THEN BOWED AND THE CUTTING WIRES WERE FACING IN THE RANGE OF 2 O'CLOCK TO 11 O'CLOCK (APPROPRIATE ORIENTATION IS APPROXIMATELY 11:00 - 1:00 O'CLOCK). PRIOR TO FUNCTIONAL TESTING, THE SPHINCTEROTOME CATHETERS WERE SUBJECTED TO A CLOSE VISUAL EXAMINATION AT THE DISTAL ENDS AS THEY LAID FLAT, AND TWISTING OF THE TUBING WAS NOT OBSERVED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENTS WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. IN FOUR (4) OF THE RETURNED DEVICES, OUR EVALUATIONS WERE UNABLE TO CONFIRM THE REPORT OF INCORRECT CUTTING WIRE ORIENTATION. DURING OUR LABORATORY ANALYSIS, THE SPHINCTEROTOMES WERE EACH 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 CATHETERS EXITED THE ENDOSCOPE WITH THE CUTTING WIRES FACING IN THE RANGE OF 1 O'CLOCK TO 12 O'CLOCK. THE DEVICES WERE THEN BOWED AND THE CUTTING WIRES WERE FACING IN THE RANGE OF 1 O'CLOCK TO 12 O'CLOCK (APPROPRIATE ORIENTATION IS APPROXIMATELY 11:00 - 1:00 O'CLOCK). PRIOR TO FUNCTIONAL TESTING, THE SPHINCTEROTOME CATHETERS WERE SUBJECTED TO A CLOSE VISUAL EXAMINATION AT THE DISTAL ENDS AS THEY LAID FLAT, AND TWISTING OF THE TUBING WAS NOT OBSERVED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBERS SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCTS THAT WERE RELEASED FOR DISTRIBUTION. 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 PRECURVED AND IS PROVIDED WITH A PRECURVED 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 IN AN ATTEMPT 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 SPHINCTEROTOME" UPON REMOVING THE DEVICE FROM THE PACKAGING. THE USER IS THEN INSTRUCTED TO "CAREFULLY REMOVE PRECURVED STYLET FROM 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 OMNI-TOME SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE LOTS SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. 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 · 0

    THIS REPORT SUMMARIZES 17 MALFUNCTION EVENTS. A REVIEW OF THE EVENT INDICATED THAT DURING SEPARATE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES, THE PHYSICIANS USED COOK FUSION OMNI-TOME SPHINCTEROTOMES. DURING THE PROCEDURES, THE USERS EXPERIENCED INCORRECT CUTTING WIRE ORIENTATION. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES ON VARIOUS DATES. ALL SEVENTEEN (17) EVENTS INVOLVED PATIENTS WITH NO REPORTED PATIENT CONSEQUENCES. ONE (1) OF THE PATIENTS INVOLVED WAS A (B)(6) MALE. ONE (1) PATIENT WAS A FEMALE, AND TWO (2) PATIENTS HAD PRE-EXISTING BILIARY STONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448497 FUSION OMNI-TOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY 00827002319035

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE, UNKNOWN MODEL| OLYMPUS ENDOSCOPE, UNKNOWN MODEL