BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTS PRECURVED ULTRA TAPER SPHINCTEROTOME

    MDR report key: 10886735 · Received November 23, 2020

    Report

    Report Number
    1037905-2020-00506
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    November 2, 2020
    Report Date
    November 23, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    00827002224292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: UNKNOWN. PMA/510(K) # K172665. INVESTIGATION EVALUATION: AN EVALUATION OF THE DEVICE CONFIRMED THE REPORT OF INCORRECT CUTTING WIRE ORIENTATION. DURING OUR LABORATORY ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT WAS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2 MM IN DIAMETER (OLYMPUS MODEL NUMBER TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 6 O¿CLOCK. PRIOR TO BEING BOWED, THE DISTAL END ENTERED THE SIMULATED PAPILLA. THE DEVICE WAS THEN ATTEMPTED TO BE BOWED AND THE CUTTING WIRE WAS FACING 6 O'CLOCK (APPROPRIATE ORIENTATION IS APPROXIMATELY 11:00 - 1:00 O'CLOCK). THE DEVICE FAILED TO BOW. A VISUAL INSPECTION DETERMINED THAT THERE WAS A BREAKAGE AT THE CENTER CANNULA, AND A COMPLETE FUNCTIONAL TEST COULD NOT BE PERFORMED. THE SPHINCTEROTOME CATHETER WAS SUBJECTED TO A CLOSE VISUAL EXAMINATION AND TWISTING OF THE TUBING WAS OBSERVED AT THE DISTAL END. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. 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 CONCLUSION: 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 PATIENT 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. A FACTOR THAT CAN CONTRIBUTE TO IMPROPER CUTTING WIRE ORIENTATION INCLUDES 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: "UPON REMOVING DEVICE FROM PACKAGE, UNCOIL AND STRAIGHTEN SPHINCTEROTOME." THE USER IS THEN INSTRUCTED TO: "CAREFULLY REMOVE PRECURVED STYLET FROM 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 UTS PRECURVED ULTRA TAPER 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 MANUFACTURING 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) PROCEDURE, THE PHYSICIAN USED A COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOME. THE ORIENTATION OF THE TIP WAS BENT IN THE OPPOSITE DIRECTION OUT OF THE PACKAGE. THE PHYSICIAN PUT IT DOWN THE ENDOSCOPE, BUT COULD NOT USE IT, PULLED IT BACK OUT OF THE ENDOSCOPE, AND USED ANOTHER TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT. 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
    1351691 UTS PRECURVED ULTRA TAPER SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY G22429 W4377626 00827002224292

    Patients

    Seq Age Sex Outcome Treatment
    1