BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    MDR report key: 3180082 · Received June 13, 2013

    Report

    Report Number
    1037905-2013-00390
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THAT THE CUTTING WIRE HAS DISCONNECTED FROM THE CATHETER AT THE DISTAL END. DUE TO THE DISCONNECTION OF THE CUTTING WIRE, THE SPHINCTEROTOME WILL NOT RESPOND TO BOWING WHEN THE HANDLE IS MANIPULATED AND THE DEVICE IS NO LONGER OPERATIONAL. THE SECURING COMPONENT AND THE BOTTOM SECTION OF THE COMPONENT ARE STILL ATTACHED TO THE CUTTING WIRE AT THE AREA OF DISCONNECTED THEREFORE WE CAN CONCLUDE NO SECTION OF THE DEVICE IS MISSING. THE CUTTING WIRE EXHIBITS EVIDENCE OF A CAUTERY APPLICATION (DISCOLORATION OF THE CUTTING WIRE WAS OBSERVED). THE AREA WHERE THE TIP OF THE CUTTING WIRE HAS DISCONNECTED FROM THE CATHETER APPEARS TORN. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. 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 PT ANATOMY 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. A SEPARATED AND/OR BROKEN CUTTING WIRE CAN OCCUR IF THE TIP OF THE DEVICE IS OVER FLEXED. THE INSTRUCTIONS FOR USE CAUTION THE USER NOT TO OVER FLEX OR BOW THE TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE THE SPHINCTEROTOME. CUTTING WIRE SEPARATION AND/OR BREAKAGE CAN OCCUR IF THE HANDLE IS MANIPULATED 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." CUTTING WIRE SEPARATION AND/OR BREAKAGE CAN ALSO OCCUR IF THE CUTTING WIRE MAKES CONTACT WITH THE ENDOSCOPE WHEN ELECTROSURGICAL CURRENT IS APPLIED TO PERFORM THE SPHINCTEROTOMY. THE INSTRUCTIONS FOR USE CAUTION THE USER TO ENSURE THE CUTTING WIRE IS COMPLETELY OUT OF THE ENDOSCOPE WHEN APPLYING THE ELECTROSURGICAL CURRENT. THE INSTRUCTIONS CAUTION THE USER THAT CONTACT OF THE CUTTING WIRE WITH THE ENDOSCOPE COULD RESULT IN BREAKAGE OF THE CUTTING WIRE. IF THE SPHINCTEROTOME IS USED WITH EXCESSIVE ELECTROSURGICAL CURRENT SETTINGS PROVIDED BY THE ELECTROSURGICAL UNIT, THIS CAN CONTRIBUTE TO CUTTING WIRE SEPARATION AND/OR BREAKAGE. THE INSTRUCTIONS FOR USE FOR THIS SPHINCTEROTOME DIRECT THE USER TO VERIFY DESIRED SETTINGS BY FOLLOWING THE ELECTROSURGICAL UNIT MANUFACTURER'S INSTRUCTIONS. IF THE ELEVATOR OF THE ENDOSCOPE REMAINS IN THE CLOSED/UP POSITION WHEN RETRACTION OF THE SPHINCTEROTOME IS ATTEMPTED AND ADDITIONAL PRESSURE IS APPLIED, THIS COULD HAVE CONTRIBUTED TO CUTTING WIRE SEPARATION AND/OR BREAKAGE. THE INSTRUCTIONS FOR USE CAUTION THE USER, THE ELEVATOR SHOULD REMAIN OPEN/DOWN WHEN ADVANCING OR RETRACTING THE SPHINCTEROTOME. THIS ACTIVITY WILL AID IN DEVICE PRESERVATION. PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOME SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES BOWING THE SPHINCTEROTOME TO ENSURE THE DISTAL END RESPONDS TO HANDLE MANIPULATION. 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 REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME WAS USED. THEY WERE PERFORMING A SPHINCTEROTOMY. THEY PERFORMED THE CUT AND WERE BOWING AND ROTATING THE SPHINCTEROTOME. THEY ROTATED THE HANDLE 360 DEGREES TWO TIMES. THEY BOWED THE DEVICE UP AND DOWN MULTIPLE TIMES. THEY TRIED TO BOW THE DEVICE AGAIN TO CONTINUE THE CUT AND THE CUTTING WIRE PULLED OUT OF THE DISTAL END OF THE SPHINCTEROTOME. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269770 FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. W3271578

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK METII-25-260 WIRE GUIDE| ERBE ELECTROSURGICAL UNIT| OLYMPUS ENDOSCOPE (UNKNOWN TYPE)| ACTIVE CORD (UNKNOWN TYPE)