BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME

    MDR report key: 3173461 · Received June 6, 2013

    Report

    Report Number
    1037905-2013-00349
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR EVAL 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 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160VR). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 9:00 O'CLOCK. THE DEVICE WAS THEN BOWED AND THE CUTTING WIRE REMAINED FACING 9:00 O'CLOCK (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). DURING THE VISUAL ANALYSIS IT WAS NOTED THAT THE CATHETER TIP AND CUTTING WIRE IS INTACT. THE DISTAL TIP OF THE SPHINCTEROTOME WAS TWISTED AND PRESENTED A S-SHAPED APPEARANCE. 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 PT 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 FUNCTION TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME. THE CUTTING WIRE ORIENTATION OF THE SPHINCTEROTOME WAS REPORTED TO BE OFF. THE PHYSICIAN REMOVED THE DEVICE FROM THE ENDOSCOPE AND PROCEEDED BY USING A SECOND COOK FUSION OMNI-TOME. THE ORIENTATION OF THE SECOND DEVICE WAS REPORTED TO BE OFF AS WELL. THE PHYSICIAN HAD THE NURSE ROTATE THE HANDLE TO CORRECT THE ORIENTATION. THEY WERE ABLE TO PERFORM A SPHINCTEROTOMY AND COMPLETE THE PROCEDURE USING THE SECOND DEVICE. THE REMOVED DEVICE FROM THE ENDOSCOPE AND ALSO FOUND THE CUTTING WIRE HAD BROKEN BUT WAS STILL ATTACHED. NO SECTION OF THE DEVICE DETACHED INSIDE THE PT. SEE MDR 1037905-2013-00350. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL RPTR, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251889 FUSION OMNI-TOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC W3256701

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK METRO II WIRE GUIDE| OLYMPUS V-ENDOSCOPE (UNK MODEL NUMBER)