BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME SPHINCTEROTOME

    MDR report key: 2062158 · Received March 18, 2011

    Report

    Report Number
    1037905-2011-00140
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR EVAL 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 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-140R). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 12:00. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1.00 O'CLOCK.). THE DEVICE HAS A SEVERE TWIST IN THE CATHETER LOCATED AT THE DISTAL END OF THE HANDLE. THE DISTAL END OF THE DEVICE HAS MULTIPLE TWIST IN THE CATHETER. THE HUB AND CATHETER CONNECTION APPEARS TO HAVE SEPARATED, UNDER THE ORANGE SHRINKTUBE. ADD'L INFO PROVIDED INDICATED THE USER OF THE SPHINCTEROTOME ROTATED THE HANDLE DURING USE TO INFLUENCE ORIENTATION OF THE SPHINCTEROTOME'S CUTTING WIRE. DURING THE ROTATION OF THE HANDLE, THE CATHETER TWISTED NEAR THE BASE OF THE HANDLE. IF A FORCEFUL ROTATION AND/OR EXCESSIVE ROTATIONS WERE USED DURING THIS TECHNIQUE, THIS COULD HAVE CONTRIBUTED TO THE REPORTED CATHETER DAMAGE. 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. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. CONCLUSIONS: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE PRODUCT SAID TO BE INVOLVED FUNCTIONED AS INTENDED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. ADD'L INFO PROVIDED INDICATED THE USER OF THE SPHINCTEROTOME ROTATED THE HANDLE DURING USE TO INFLUENCE ORIENTATION OF THE SPHINCTEROTOME'S CUTTING WIRE. DURING THE ROTATION OF THE HANDLE, THE CATHETER TWISTED NEAR THE BASE OF THE HANDLE. IF A FORCEFUL ROTATION AND/OR EXCESSIVE ROTATIONS WERE USED DURING THIS TECHNIQUE, THIS COULD HAVE CONTRIBUTED TO THE REPORTED CATHETER DAMAGE. PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOME 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 MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT COULD NOT BE VERIFIED. THIS TYPE OF OCCURRENCE HAS BEEN BROUGHT TO THE ATTENTION OF THE APPROPRIATE INTERNAL PERSONNEL IN AN EFFORT TO HEIGHTEN AWARENESS. NO FURTHER ACTION WAS TAKEN AT THIS TIME. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME SPHINCTEROTOME. THE SPHINCTEROTOME WAS ADVANCED INTO POSITION AND CUTTING WIRE ORIENTATION WAS REPORTED TO BE INCORRECT. THE HANDLE WAS ROTATED IN AN ATTEMPT TO MANIPULATE CUTTING WIRE ORIENTATION, CAUSING DAMAGE TO THE CATHETER. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. 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 REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION OMNI-TOME SPHINCTEROTOME KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES KNS WILSON-COOK MEDICAL, INC. W2964221

    Patients

    Seq Age Sex Outcome Treatment
    1 PENTAX ENDOSCOPE (UNK MODEL NUMBER)