BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME

    MDR report key: 19357728 · Received May 21, 2024

    Report

    Report Number
    1037905-2024-00274
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 25, 2024
    Report Date
    June 28, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    UDI-DI
    10827002225579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K172665 INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. SEPARATION OF THE CUTTING WIRE SECURING COMPONENT AND THE CATHETER CAN OCCUR IF THE TIP OF THE SPHINCTEROTOME IS OVER FLEXED. THE INSTRUCTIONS FOR USE CAUTION THE USER WITH THE FOLLOWING COMMENT: ¿DO NOT OVER FLEX OR BOW THE TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE OR CAUSE THE CUTTING WIRE TO BREAK.¿ PRIOR TO DISTRIBUTION, ALL TRI-TOME PC TRIPLE LUMEN 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: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. 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

    AN EMDR REPORT WAS INITIALLY SENT ON 21 MAY 2024, BASED ON THE INFORMATION THAT THE CUTTING WIRE OF THE SPHINCTEROTOME AT ONE END [DISCONNECTED] AND IT WAS STILL CONNECTED AT THE OTHER END WITH THE SPHINCTEROTOME; THIS INFORMATION WAS INTERPRETED AS ANCHOR SEPARATION WITHOUT DETACHMENT, WHICH IS AN MDR REPORTABLE EVENT. THE DEVICE WAS RETURNED ON 3 JUN 2024 AND PER OUR EVALUATION OF THE DEVICE IT WAS FOUND THAT THE ANCHOR HAS NOT SEPARATED, BUT THE CUTTING WIRE HAS BROKEN WITHOUT DETACHMENT. THIS MALFUNCTION HAS NOT HISTORICALLY CAUSED OR CONTRIBUTED TO A SERIOUS INJURY NOR DEATH. BASED ON THE PRODUCT EVALUATION INFORMATION, THIS INCIDENT NO LONGER MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT.

    Description of Event or Problem · 0

    DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES, THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. IT WAS REPORTED THAT THE CUTTING WIRE OF THE SPHINCTEROTOME AT ONE END [DISCONNECTED], IT WAS STILL CONNECTED AT THE OTHER END WITH THE SPHINCTEROTOME [ANCHOR SEPARATION WITHOUT DETACHMENT], SO IT COULD BE REMOVED WITHOUT DIFFICULTY. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THIS LENGTHENED THE PROCEDURE BECAUSE A NEW SPHINCTEROTOME HAD TO BE USED. 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.

    Description of Event or Problem · 0

    THIS CORRECTION FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED RELATING TO THIS EVENT. REFERENCE THE SECTION H10- ADDITIONAL MANUFACTURER NARRATIVE-NOTES FOR THIS JUSTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584678 TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC W4768863 10827002225579

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ENDOSCOPE, UNKNOWN MAKE AND MODEL