BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    MDR report key: 3807248 · Received March 19, 2014

    Report

    Report Number
    1037905-2014-00097
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 17, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    OF THE TWO (2) DEVICES DESCRIBED, ONLY ONE (1) USED DEVICE FROM THE LOT NUMBER PROVIDED IN THE REPORT WAS MADE AVAILABLE FOR EVALUATION. 1037905-2014-001096: ONLY ONE (1) USED DEVICE RETURNED ON (B)(4) 2014. 1037905-2014-00097: NOT AVAILABLE FOR EVALUATION. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT FOR THIS DEVICE COLD NOT BE CONFIRMED. 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 PRE-CURVED STYLET IN THE DISTAL TIP OF THE CATHETER. THIS OBVIATES THE NEED FOR MANUAL FORMATION. THE INSTRUCTIONS FOR USE CONTAIN 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 PRE-CURVED STYLET INSIDE THE ANNULATING 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 PRECURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE TO SPHINCTEROTOME AND RENDER IT INOPERABLE." PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TONE 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

    THE FOLLOWING WAS OBSERVED WITH TWO (2) COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOMES. WHEN THE PHYSICIAN STARTED TO USE THE PRODUCT THEY OBSERVED VERY BAD ORIENTATION. THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS. SEE MDRS 1037905-2014-00096 AND 1037905-2014-00097. 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 EFFECT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163470 FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. W3370414

    Patients

    Seq Age Sex Outcome Treatment
    1