BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED)

    MDR report key: 19264980 · Received May 7, 2024

    Report

    Report Number
    9614641-2024-01046
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    February 20, 2024
    Report Date
    June 28, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170371172
    PMA / PMN Number
    K141991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS RELATED TO MFR 241626 (2/2).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT (G2 AND H8). THE SUBJECT DEVICE WAS MANUFACTURED ON JAN 2023 BASED ON THE PROVIDED 3 DIGIT LOT INFORMATION. HOWEVER, THE EXACT MANUFACTURE DATE IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION AND PAST INVESTIGATION RESULTS, IT IS LIKELY THE MECHANISM CAUSING THE BREAKAGE OF THE CUTTING WIRE MIGHT BE THE FOLLOWING: 1) THE DEVICE WAS ENERGIZED IN ONE OF THESE FOLLOWING SITUATIONS. (A) THE CUTTING WIRE IS IN POINT CONTACT WITH TISSUE. OR THEY WERE BEING CLOSE TO EACH OTHER. (B) THE CUTTING WIRE IS IN POINT CONTACT WITH DISTAL END OF ENDOSCOPE. OR THEY WERE BEING CLOSE TO EACH OTHER. 2) AN ELECTRICAL DISCHARGE OCCURRED IN THE CUTTING WIRE, AND THE CUTTING WIRE BECAME HOT INSTANTLY. 3) THE CUTTING WIRE WAS BROKEN. HOWEVER, THE SUBJECT DEVICE WAS NOT RETURNED, AND THE ROOT CAUSE OF THE SUGGESTED EVENT COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "SINCE THE CUTTING WIRE IS VERY THIN, IT MAY BREAK OFF IN THE FOLLOWING CASES: THE DISTANCE BETWEEN THE PAPILLA OF VATER AND THE CUTTING WIRE IS VERY SHORT, THE OUTPUT IS TOO HIGH OR ACTIVATED WHILE THE CUTTING WIRE TOUCHES METAL PARTS OF THE ENDOSCOPE, OR THE CUTTING WIRE IS TIGHTENED TOO STRONG. WHEN THE CUTTING WIRE BREAKS OFF, ITS PROXIMAL END WILL BE RETRACTED TOWARD THE ENDOSCOPE IF THE SLIDER IS PULLED. IF THE SLIDER IS PUSHED, THE CUTTING WIRE WILL BE PUSHED OUT TOWARD THE PAPILLA OR MOVE SIDEWAYS. IF THE CUTTING WIRE BREAKS OFF, STOP THE OUTPUT IMMEDIATELY AND PULL THE SLIDER COMPLETELY TO RETRACT THE BROKEN CUTTING WIRE INTO THE TUBE. THEN WITHDRAW THE SPHINCTEROTOME FROM THE PAPILLA. OTHERWISE, PATIENT INJURY, SUCH AS PERFORATIONS, BLEEDING, OR LACERATIONS WITHIN THE BILIARY DUCT, AND/OR DAMAGE OF THE ENDOSCOPE COULD RESULT." "WHEN ACTIVATING OUTPUT, SET THE OUTPUT MODE OF THE ELECTROSURGICAL UNIT TO ¿CUT¿ OR ¿BLEND¿. ACTIVATING OUTPUT IN THE ¿COAGULATION¿ MODE COULD BREAK THE CUTTING WIRE." "WHEN INSERTING THE INSTRUMENT INTO THE ENDOSCOPE, BE SURE THAT THE CUTTING WIRE IS PARALLEL TO THE TUBE. OTHERWISE, THE METAL PART OF THE FORCEPS ELEVATOR MAY CONTACT THE CUTTING WIRE AND PEEL OFF THE COATING MATERIAL." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SPHINCTEROTOME EXPERIENCED SPLITTING OF THE CUTTING/CAUTER GUIDEWIRE. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782650 SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED) SINGLE USE PRELOADED SPHINCTEROTOME KNS AOMORI OLYMPUS CO., LTD. KD-VC431Q-0720 31V 04953170371172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown