BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME SPHINCTEROTOME

    MDR report key: 1791430 · Received August 6, 2010

    Report

    Report Number
    1037905-2010-00365
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Report Date
    July 7, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K05051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: WE COULD NOT CONFIRM THE REPORT BECAUSE THE AFFECTED PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. ADD¿L UNUSED SPHINCTEROTOMES FROM THE SAME LOT IN THE REPORT WERE RETURNED FOR EVAL. DURING OUR LABORATORY ANALYSIS, THE SPHINCTEROTOMES WERE ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. HALF OF THE UNUSED PRODUCT FUNCTIONED AS INTENDED. THE OTHER HALF DISPLAYED CUTTING WIRE ORIENTATION OUTSIDE OF THE EXPECTED CUTTING WIRE ORIENTATION WINDOW (11 O¿CLOCK TO 1 O¿CLOCK). THE CUTTING WIRE ORIENTATION OF THESE SPHINCTEROTOMES NEEDED CORRECTION BY ADJUSTING THE DUODENOSCOPE SO THAT THE CUTTING WIRE FACED THE 11 O¿CLOCK ¿ 1 O¿CLOCK AREA. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THESE RESULTS HAS NOT BEEN DETERMINED AT THIS TIME. HOWEVER, FURTHER INVESTIGATION BY THE APPROPRIATE INTERNAL PERSONNEL IS BEING CONDUCTED IN RESPONSE TO THESE RESULTS. AFTER A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT USED DURING THE PROCEDURE WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. 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 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 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: THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN INFORMED OF THIS OCCURRENCE AND FURTHER INVESTIGATION IS UNDERWAY; NO FURTHER ACTION WARRANTED 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 ENDOSCOPY FUSION OMNI-TOME SPHINCTEROTOME. THE SPHINCTEROTOME WAS ADVANCED THROUGH THE ENDOSCOPE. WHEN THE SPHINCTEROTOME EXITED THE ENDOSCOPE, THE ORIENTATION WAS AT 8:00 O¿CLOCK. THE CUTTING WIRE APPEARED TO BE TWISTING ON THE CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PATIENT. NO ADD¿L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION OMNI-TOME SPHINCTEROTOME KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES KNS COOK ENDOSCOPY W2870796

    Patients

    Seq Age Sex Outcome Treatment
    1