BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    MDR report key: 2945257 · Received February 1, 2013

    Report

    Report Number
    1037905-2013-00052
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Report Date
    January 17, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE BREAKTHROUGH CHANNEL HAS BEEN UTILIZED FULLY. THE OUTER EDGES OF THE CHANNEL ARE SLIGHTLY RIPPLED AND TORN. THERE ARE TWISTS IN THE TUBING., ALTHOUGH TWISTING OF THE TUBING HAS NOT BEEN IDENTIFIED AS A CAUSE FOR DIFFICULTY WITH THE BREAKTHROUGH CHANNEL. SINCE THE BREAKTHROUGH CHANNEL HAS BEEN FULLY UTILIZED, FUNCTIONAL TESTING OF THE ZIP EXCHANGE CHANNEL WAS UNABLE TO BE PERFORMED. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. 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: RESISTANCE IN WIRE GUIDE AND WIRE GUIDE LUMEN SEPARATION CAN OCCUR IF THE CATHETER OF THE SPHINCTEROTOME BECOMES DAMAGED (I.E. KINK OR BEND). A KINK IN THE SPHINCTEROTOME CAN OCCUR IF THE DEVICE RECEIVES ADDED PRESSURE DURING ADVANCEMENT THROUGH THE ENDOSCOPE OR GENERAL HANDLING. THE INSTRUCTIONS FOR USE CAUTION THE USER THE ELEVATOR SHOULD REMAIN OPEN/DOWN WHEN ADVANCING OR RETRACTING THE SPHINCTEROTOME. IF THE ELEVATOR OF THE ENDOSCOPE IS PLACED IN THE CLOSED/UP POSITION WITH THE SPHINCTEROTOME INSIDE THE ACCESSORY CHANNEL, THIS COULD CAUSE A KINK IN THE SPHINCTEROTOME AND LEAD TO WIRE GUIDE AND WIRE GUIDE LUMEN SEPARATION DIFFICULTY. INSTRUCTIONS FOR USE STATES FOR BEST RESULTS WIRE GUIDE SHOULD BE KEPT WET. PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOME SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING 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: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF DIFFICULTY WITH SPLITTING THE BREAKTHROUGH CHANNEL. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME WAS USED. THE ENDOSCOPE WAS PLACED IN THE ACCURATE POSITION AND THE SPHINCTEROTOME WAS USED TO CANNULATE THE COMMON BILE DUCT (CBD). THE WIRE GUIDE WAS ADVANCED. SPHINCTEROTOMY WAS PERFORMED. THE WIRE GUIDE WAS FIXED IN THE WIRE LOCKING DEVICE AND THE NURSE BEGAN TO SPLIT THE BREAKTHROUGH CHANNEL OF THE SPHINCTEROTOME. THE DOCTOR PULLED THE SPHINCTEROTOME TO PERFORM A SHORT WIRE GUIDE EXCHANGE. DIFFICULTY WITH SPLITTING THE BREAKTHROUGH CHANNEL LUMEN WAS ENCOUNTERED AND AFTER 2 CM OF PULLING, THE WIRE GUIDE CAME BACK UP. THE WIRE GUIDE LOOPED UP FOR 10 CM AND EVEN COILED AROUND THE WIRE LOCKING DEVICE. IN OUR ATTEMPT TO COLLECT ADDITIONAL INFORMATION REGARDING THIS OCCURRENCE, THE MEDICAL FACILITY MADE THE FOLLOWING COMMENT TO THE COOK AREA REP: "THIS RESULTED IN LOSS OF DUCTAL ACCESS IN ABOUT 80% OF THE CASES. THE OTHER 20% THE WIRE WAS BARELY INSIDE THE DUCT AND NEEDED TO BE REPOSITIONED." A SPECIFIC QUANTITY COULD NOT BE PROVIDED, ONLY THE APPROXIMATION. ASSIGNMENT OF THIS COMMENT TO SPECIFIC EVENTS COULD NOT BE PERFORMED BASED ON THE INFORMATION MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44500 FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES KNS WILSON-COOK MEDICAL INC W3207910

    Patients

    Seq Age Sex Outcome Treatment
    1 FS-WL-O-S WIRELOCK| OLYMPUS 180 SERIES DUODENOSCOPE,