BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME

    MDR report key: 3952488 · Received May 14, 2014

    Report

    Report Number
    1037905-2014-00183
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 14, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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 9 O' CLOCK. THE DEVICE WAS THEN BOWED AND THE CUTTING WIRE WAS FACING 10 O'CLOCK (APPROPRIATE ORIENTATION IS APPROXIMATELY 11:00 - 1:00 O'CLOCK). THE SPHINCTEROTOME CATHETER WAS SUBJECTED TO A CLOSE VISUAL EXAMINATION 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 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 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 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 PRE-CURVED 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 PRE-CURVED STYLET FROM THE CANNULATING TIP. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT EXERCISE HANDLE WHILE DEVICE IS COILED OR PRE-CURVED 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. 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. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT. THE INSTRUCTIONS FOR USE NOTES STATE: VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPY PROCEDURE, A COOK FUSION OMNI-TOME SPHINCTEROTOME WAS USED. AFTER CAREFULLY REMOVING THE STYLET, THE TIP ORIENTATION WAS NOT GOOD (INCORRECT CUTTING WIRE ORIENTATION). THE PHYSICIAN DECIDED TO USE THE DEVICE FOR THE PROCEDURE. NO HARM WAS DONE TO THE PATIENT. 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
    288233 FUSION OMNI-TOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1