BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME

    MDR report key: 3082573 · Received April 24, 2013

    Report

    Report Number
    1037905-2013-00168
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K901443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT THAT THE CUTTING WIRE WAS BROKEN. DURING THE VISUAL EXAMINATION IT WAS CONFIRMED THE CUTTING WIRE WAS BROKEN ON THE PROXIMAL END. THE CUTTING WIRE IS SECURELY ENCASED IN THE SPHINCTEROTOME TIP AT THE DISTAL END. THE SECURING COMPONENT REMAINS ATTACHED TO THE CUTTING WIRE, AND THE TAIL IS ATTACHED TO THE SECURING COMPONENT. THE PROXIMAL END OF THE CUTTING WIRE WAS FURTHER EXAMINED AND A DIMENSIONAL ANALYSIS WAS CONDUCTED. IT WAS DETERMINED THAT THE CUTTING WIRE MEASURES LESS THAN SPECIFICATIONS. THE SKIVE IS BADLY BURNT AS IS THE PROXIMAL END OF THE CUTTING WIRE. IT IS REASONABLE TO SUGGEST THAT A SMALL PORTION OF THE PROXIMAL END OF THE CUTTING WIRE IS MISSING. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. 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 PATIENT ANATOMY, ENDOSCOPE POSITION OR DISEASE STATED, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. A SEPARATED AND/OR BROKEN 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. CUTTING WIRE SEPARATION AND/OR BREAKAGE CAN OCCUR IF THE HANDLE IS MANIPULATED 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." CUTTING WIRE SEPARATION AND/OR BREAKAGE CAN ALSO OCCUR IF THE CUTTING WIRE MAKES CONTACT WITH THE ENDOSCOPE WHEN ELECTROSURGICAL CURRENT IS APPLIED TO PERFORM THE SPHINCTEROTOMY. THE INSTRUCTIONS FOR USE CAUTION THE USER TO ENSURE THE CUTTING WIRE IS COMPLETELY OUT OF THE ENDOSCOPE WHEN APPLYING ELECTROSURGICAL CURRENT. THE INSTRUCTIONS CAUTION THE USER THAT CONTACT OF THE CUTTING WIRE WITH THE ENDOSCOPE COULD RESULT IN BREAKAGE OF THE CUTTING WIRE. IF THE SPHINCTEROTOME IS USED WITH EXCESSIVE ELECTROSURGICAL CURRENT SETTINGS PROVIDED BY THE ELECTROSURGICAL UNIT, THIS CAN CONTRIBUTE TO CUTTING WIRE SEPARATION AND/OR BREAKAGE. THE INSTRUCTIONS FOR USE SPHINCTEROTOME DIRECT THE USER TO VERIFY DESIRED SETTINGS BY FOLLOWING THE ELECTROSURGICAL UNIT MANUFACTURER'S INSTRUCTIONS. IF THE ELEVATOR OF THE ENDOSCOPE REMAINS IN THE CLOSED/UP POSITION WHEN RETRACTION OF THE SPHINCTEROTOME IS ATTEMPTED AND ADDITIONAL PRESSURE IS APPLIED, THIS COULD HAVE CONTRIBUTED TO CUTTING WIRE SEPARATION AND/OR BRAKEAGE. THE INSTRUCTIONS FOR USE CAUTION THE USER THE ELEVATOR SHOULD REMAIN OPEN/DOWN WHEN ADVANCING OR RETRACTING THE SPHINCTEROTOME. THIS ACTIVITY WILL AID IN DEVICE PRESERVATION. PRIOR TO DISTRIBUTION, ALL TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES BOWING THE SPHINCTEROTOME TO ENSURE THE DISTAL END RESPONDS TO HANDLE MANIPULATION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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

    THE FOLLOWING INFORMATION WAS INITIALLY PROVIDED TO COOK. DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME WAS USED. THE CUTTING WIRE WAS BROKEN AND THE DEVICE COULD NOT BE USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO SECTION OF THE DEVICE DETACHED INSIDE THE PATIENT. WHEN THE PRODUCT WAS RECEIVED OUR EVALUATION RESULTS CONFIRMED A SMALL SECTION OF THE CUTTING WIRE HAD DETACHED AND WAS NOT INCLUDED IN THE RETURN. THIS TYPE OF OCCURRENCE HAS BEEN ESTABLISHED AS A REPORTABLE EVENT. INFORMATION REGARDING THE MISSING SECTION WAS COMMUNICATED BACK TO THE MEDICAL FACILITY. THE LOCATION OF THE MISSING SECTION IS UNKNOWN. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY; HOWEVER THE LOCATION OF THE MISSING SECTION DETECTED DURING OUR LABORATORY EVALUATION IS UNKNOWN. 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
    175679 TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. W3221475

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR ERBE ICC 200 ELECTROSURGICAL UNIT| OLYMPUS ENDOSCOPE (UNKNOWN MODEL NUMBER)| METII-35-480 WIRE| ACTIVE CORD (UNKNOWN TYPE)