BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME

    MDR report key: 12968347 · Received December 9, 2021

    Report

    Report Number
    1037905-2021-00677
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 10, 2021
    Report Date
    January 5, 2022
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    10827002225555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K172665. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. A VISUAL INSPECTION OF THE CATHETER WAS PERFORMED AND THE DISTAL TIP OF THE DEVICE APPEARS TO BE DISTORTED/DAMAGED. IT IS NOT KNOWN AT WHAT POINT THE DISTAL TIP BECAME DISTORTED/DAMAGED. NO SECTION OF THE SPHINCTEROTOME DEVICE WAS MISSING, AND THE DEVICE RESPONDED PROPERLY TO HANDLE MANIPULATION. THE CUTTING WIRE SECURING COMPONENT (ANCHOR) ALSO REMAINS FULLY ATTACHED TO THE CATHETER. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. 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. DAMAGE TO THE CATHETER TIP CAN OCCUR IF THE PRECURVED STYLET IS FORCEFULLY REMOVED. THE INSTRUCTIONS FOR USE INSTRUCT THE USER: ¿UPON REMOVING DEVICE FROM PACKAGE, UNCOIL AND STRAIGHTEN SPHINCTEROTOME. CAREFULLY REMOVE PRECURVED STYLET FROM CANNULATING TIP." IF THE ELEVATOR OF THE ENDOSCOPE REMAINS IN THE CLOSED/UP POSITION WHEN RETRACTION OF THE SPHINCTEROTOME IS ATTEMPTED AND IF ADDITIONAL PRESSURE IS APPLIED, THIS COULD CONTRIBUTE TO DAMAGE AT THE CATHETER TIP. THE INSTRUCTIONS FOR USE CAUTION THE USER: "ELEVATOR SHOULD REMAIN OPEN/DOWN WHEN ADVANCING OR RETRACTING SPHINCTEROTOME." THIS ACTIVITY WILL AID IN DEVICE PRESERVATION. THE INSTRUCTIONS FOR USE ALSO ADVISE THE USER TO: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." PRIOR TO DISTRIBUTION, ALL TRI-TOME PC PROTECTORS 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.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K172665. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. IT WAS REPORTED THAT THE TIP OF THE SPHINCTEROTOME HAS SHARP EXTRA PLASTIC SHEET [SITTING] OUT, WHICH IS CAUSING TRAUMA DURING CANNULATION. ANOTHER TOME WAS USED. THE DEVICE WAS RECEIVED AND HAD DAMAGE AT THE DISTAL END. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE DEVICE CAUSED TRAUMA, BUT NO ADDITIONAL PROCEDURE OR INTERVENTION INFORMATION WAS PROVIDED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865715 TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY W4432857 10827002225555

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ERBE ELECTROSURGICAL GENERATOR.| OLYMPUS 170 ENDOSCOPE.