BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    MDR report key: 2844743 · Received November 8, 2012

    Report

    Report Number
    1037905-2012-00626
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT DETECTED NO DEFECT WITH THE PRODUCT. HOWEVER, THE REPORT IS CONFIRMED AS THE ACTUAL USE CONDITIONS COULD NOT BE EXACTLY DUPLICATED IN THE LABORATORY SETTING. DURING THE VISUAL ANALYSIS IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE WERE INTACT AND THE PRODUCT DID NOT EXHIBIT SIGNS OF DEFORMATION. 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 12:00 O'CLOCK. THE DEVICE WAS THEN BOWED AND THE CUTTING WIRE REMAINED FACING 12:00 O'CLOCK. (APPROPRIATE ORIENTATION IS APPROXIMATELY (B)(4)). 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 NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: 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 THE 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 OMNI-TOME 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 THE PROCEDURE, A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME WAS USED. THERE WAS A LEFT LATERAL DEVIATION WITH THIS PRODUCT [INCORRECT CUTTING WIRE ORIENTATION] AND THE OPERATION WAS NOT COMPLETED SUCCESSFULLY [WITH THIS PRODUCT]. ANOTHER PRODUCT WAS USED TO FINISH THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES KNS WILSON-COOK MEDICAL INC. W3168279

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS TJF ENDOSCOPE: MODEL #UNK