BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME

    MDR report key: 3904635 · Received May 22, 2014

    Report

    Report Number
    1037905-2014-00203
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Report Date
    April 25, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM THE REPORT OF INCORRECT CUTTING WIRE ORIENTATION. DURING OUR 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 ORIENTATION OF THE CATHETER EXITING THE ENDOSCOPE COULD NOT BE DETERMINED DUE TO THE RETURN CONDITION OF THE DEVICE. FURTHER INVESTIGATION CONFIRMED A BREAK IN THE CENTER CANNULA OF THE DEVICE RESULTING IN THE CUTTING WIRE LOCATED AT THE DISTAL END OF THE SPHINCTEROTOME WILL NOT RESPOND TO HANDLE MANIPULATION. THE BREAK IS LOCATED AT APPROXIMATELY 20 EM FROM THE DISTAL END OF THE SPHINCTEROTOME. THE AREA OF THE BREAK AND DISCONNECTION IS LOCATED INSIDE THE OUTER CATHETER; NO SECTION OF THE DEVICE IS MISSING. THE SPHINCTEROTOME WAS DISASSEMBLED AND THE CENTER CANNULA JOINT AREA WAS SUBJECTED TO A VISUAL INSPECTION. THE BREAK IS LOCATED AT THE PROXIMAL END OF THE CANNULA NEAREST TO THE HANDLE AND ALL JOINTS ON THE CANNULA ARE INTACT. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVALUATION. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. 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." SEPARATION OF THE DRIVE WIRE FROM THE 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. 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 CONSTRICT MOVEMENT OF THE DRIVE WIRE WHEN THE HANDLE IS MANIPULATED IN AN ATTEMPT TO BOW THE SPHINCTEROTOME. IF ADDED PRESSURE IS APPLIED TO THE HANDLE WITH THE ELEVATOR AND SPHINCTEROTOME IN THIS POSITION, THIS COULD CONTRIBUTE TO DRIVE WIRE SEPARATION FROM THE CUTTING WIRE. OTHER FACTORS THAT CAN CONTRIBUTE TO DRIVE WIRE SEPARATION 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.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-- TOME SPHINCTEROTOME. ONCE THE SPHINCTEROTOME WAS ADVANCED THRU THE ENDOSCOPE AND AFTER CANNULATION WAS PERFORMED, AT THIS POINT, IT WAS TIME TO PERFORM THE SPHINCTEROTOMY. WHEN THE NURSE BOWED THE SPHINCTEROTOME, THE ORIENTATION OF THE CUTTING WIRE WENT TOWARDS THE 2 O'CLOCK POSITION (IT SHOULD BE AT 11 O'CLOCK). THE PHYSICIAN WAS ABLE TO MANIPULATE THE DEVICE JUST ENOUGH TO COMPLETE THE PROCEDURE WITH THE COMPLAINT DEVICE. 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
    306582 FUSION OMNI-TOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON SCIENTIFIC JAGWIRE (UNK MODEL NUMBER)| OLYMPUS 180 ENDOSCOPE (UNK MODEL NUMBER)