BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 17222684 · Received June 29, 2023

    Report

    Report Number
    9614641-2023-00922
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    May 29, 2023
    Report Date
    June 29, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170184017
    PMA / PMN Number
    K950166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED AND EVALUATED. THE MODEL NO. WAS CONFIRMED TO BE KD-V411M-0720. THE LOT NUMBER WAS 2YV WITH SUPPLEMENTARY INFORMATION NUMBER OF ¿14¿. (MANUFACTURE DATE: 14 NOV , 2022) DEVICE EVALUATION CONFIRMED THE REPORTED ISSUE. THE DEVICE EVALUATION FOUND THAT THE CUTTING WIRE WAS BROKEN, SCORCHED AND MELTED AND THE COATED PORTION OF THE CUTTING WIRE WAS TORN. THE OUTER DIAMETER OF THE CUTTING WIRE WAS MEASURED. THE RESULT INDICATED NO ABNORMALITIES. THE LENGTH OF THE COATED PORTION OF THE CUTTING WIRE, AND THE CUTTING WIRE ITSELF PRESENTED NO ABNORMALITIES. THERE WERE NO MISSING PARTS IN THE SUBJECT DEVICE. THE DEVICE HISTORY RECORD ( DHR) WITH THE LOT NUMBER OF THE SUBJECT DEVICE WAS CONFIRMED. NO ABNORMALITIES DETECTED IN THE DHR FOR THE FOLLOWING ITEMS WHICH RELATED TO THE REPORTED PHENOMENON. PROCESS INSPECTION SHEET QUALITY INSPECTION SHEET NONCONFORMING PRODUCT REPORT INSTRUCTIONS FOR USE (IFU): THIS INSTRUCTION MANUAL CONTAINS THE FOLLOWING INFORMATION. (DRAWING NO.GK6224 REVISION NO.9) . 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 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. DO NOT ACTIVATE OUTPUT WHILE TISSUE IS IN CONTACT WITH THE TORN OR DAMAGED COATED PORTION OF THE DISTAL END. IF OUTPUT IS ACTIVATED WHILE TISSUE IS CONTACTING THE TORN OR DAMAGED COATED PORTION DUE TO INSERTION INTO OR WITHDRAWAL FROM AN ENDOSCOPE, LEAKAGE CURRENT, DECREASED OUTPUT, AND/OR THERMAL INJURY COULD RESULT. IF YOU FEEL THE CUTTING IS BLUNT, WITHDRAW THE DEVICE FROM THE SCOPE TO EXAMINE IF THERE IS ANY PEEL OFF AND TEAR AT THE COATING PORTION. THE ROOT CAUSE OF EVENT COULD NOT BE CONCLUSIVELY IDENTIFIED . HOWEVER, BASED ON THE RESULT OF CONFIRMATION OF THE DEVICE, AND THE RESULT OF PAST SIMILAR COMPLAINT INVESTIGATION, A LIKELY MECHANISM CAUSING THE CUTTING WIRE BREAKAGE MIGHT BE THE FOLLOWING. 1. THE CUTTING WIRE WHERE THE WIRE COATING WAS TORN CAME INTO CONTACT WITH THE DISTAL END OF THE ENDOSCOPE WHEN THE FORCEPS ELEVATOR WAS RAISED. 2. UNDER CIRCUMSTANCES DESCRIBED ABOVE DESCRIPTION #1 1, AN ELECTRIC CONDUCTION WAS ACTIVATED. THIS CAUSED THE CUTTING WIRE TO BECOME HOT INSTANTLY AT THE CONTACT POINT. AS A RESULT, THE CUTTING WIRE BROKE. A LIKELY FACTOR CAUSING TEARS OF THE COATED PORTION OF THE CUTTING WIRE MIGHT BE THE FOLLOWING. HOWEVER, THE EXACT CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE SLIDER WAS SLIGHTLY PUSHED CAUSING THE CUTTING WIRE TO DEFLECT. THE COATED PORTION OF THE CUTTING WIRE HAS POSSIBLY BEEN RUBBED DUE TO THE EFFECT OF CONTACTING A METAL AREA OF THE ENDOSCOPE. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Description of Event or Problem · 0

    ON BEHALF OF THE CUSTOMER, AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE KNIFE WIRE SPARKED AND BROKE WHEN USING SINGLE USE 3-LUMEN SPHINCTEROTOME V. THERE WAS NO DAMAGE OR BURNS. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THERE ARE NO HEALTH HAZARDS FROM THIS EVENT. THERE WAS NO REPORT OF DELAY OR HARM TO THE PATIENT OR USER ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423128 SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME KNS AOMORI OLYMPUS CO., LTD. KD-V411M-0720 2YV 04953170184017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown