BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 14709056 · Received June 15, 2022

    Report

    Report Number
    8010047-2022-10137
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 14, 2022
    Report Date
    June 15, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    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 RECEIVED AND EVALUATED. THE MODEL NO. WAS KD-V411M-0725. THE LOT NUMBER WAS 1YK WITH SUPPLEMENTARY INFORMATION NUMBER OF ¿10¿. (M-BC MANUFACTURE DATE: NOV 10, 2021) DEVICE EVALUATION, THE FOLLOWING WERE NOTED: THE CUTTING WIRE WAS BROKEN. INVESTIGATION WAS CARRIED OUT TO CONFIRM THE BROKEN PORTION. THE BROKEN PORTION WAS SCORCHED AND MELTED. 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 FOLLOWING DEVICE HISTORY RECORD WITH THE LOT NO OF THE SUBJECT DEVICE WAS CONFIRMED. NO ABNORMALITIES FOUND FROM THE DEVICE HISTORY RECORD OF THE ITEMS WHICH RELATE TO THE REPORTED PHENOMENON. -PROCESS INSPECTION SHEET, -QUALITY INSPECTION SHEET, -NONCONFORMING PRODUCT REPORT. IFU (INSTRUCTION FOR USE) :THE INSTRUCTION MANUAL (DRAWING NO. GK6224, REVISION NO.8) CONTAINS THE FOLLOWING INFORMATION. THEREFORE, IT WOULD BE POSSIBLE TO PREVENT THIS EVENT FROM OCCURRING. ¿ SINCE THE CUTTING WIRE IS VERY THIN, IT MAY BREAK OFF IN THE FOLLOWING CASES: THE DISTANCE BETWEEN THE PAPILLA OF VATER AND THE WIRE IS VERY SHORT, THE OUTPUT IS TOO HIGH OR ACTIVATED WHILE THE WIRE TOUCHES METAL PARTS OF THE ENDOSCOPE, OR THE WIRE IS TIGHTENED TOO STRONG. WHEN THE WIRE BREAKS OFF, ITS PROXIMAL END WILL BE RETRACTED TOWARD THE ENDOSCOPE IF THE SLIDER IS PULLED. IF THE SLIDER IS PUSHED, THE WIRE WILL BE PUSHED OUT TOWARD THE PAPILLA OR MOVE SIDEWAYS. IF THE WIRE BREAKS OFF, STOP THE OUTPUT IMMEDIATELY AND PULL THE SLIDER COMPLETELY TO RETRACT THE BROKEN WIRE INTO THE TUBE. THEN WITHDRAW THE INSTRUMENT FROM THE PAPILLA. OTHERWISE, PATIENT INJURY, SUCH AS PERFORATIONS, BLEEDING, OR LACERATIONS WITHIN THE BILIARY DUCT AND/OR DAMAGE OF THE ENDOSCOPE COULD RESULT. ¿BE SURE THAT THE REAR END OF THE CUTTING WIRE IS EXTENDED FROM THE DISTAL END OF THE ENDOSCOPE. IN CASE THE CUTTING WIRE CONTACTS THE FORCEPS ELEVATOR, INSUFFICIENT OUTPUT OR UNINTENDED TISSUE INJURY MAY OCCUR. ¿ DO NOT ACTIVATE OUTPUT WHILE THE CUTTING WIRE TOUCHES THE METAL PARTS OF THE ENDOSCOPE, OR THEY ARE BEING CLOSE TOGETHER. THIS COULD BURN THE TISSUE AND/OR DAMAGE THE ENDOSCOPE OR THE INSTRUMENT. BASED ON THE RESULTS OF CONFIRMATION OF THE DEVICE AND THE INVESTIGATION RESULTS IN THE PAST, A LIKELY MECHANISM CAUSING THE BROKEN CUTTING WIRE MIGHT BE THE FOLLOWING. 1. THE DEVICE WAS NOT PROTRUDED ENOUGH FROM THE ENDOSCOPE UNTIL THE REAR END OF THE CUTTING WIRE WAS IN THE FIELD OF VIEW. 2. DUE TO THE SITUATION OF ¿1¿ DESCRIPTION, THE CUTTING WIRE AND THE ENDOSCOPE WERE BEING CLOSE TO EACH OTHER. 3. THE OUTPUT WAS ACTIVATED IN STATE OF ¿2¿ DESCRIPTION. THIS MIGHT HAVE LED TO AN ELECTRICAL DISCHARGE BETWEEN THE CUTTING WIRE AND THE DISTAL END OF THE ENDOSCOPE. 4. AN ELECTRICAL DISCHARGE POSSIBLY OCCURRED, AND THE CUTTING WIRE BECAME HOT INSTANTLY. THAT MIGHT HAVE CAUSED THE CUTTING WIRE TO BREAK. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ) PROCEDURE, THE KNIFE WIRE BROKE AT THE FIRST ENERGIZATION. ACCORDING TO THE REPORTER, IT USES VIO3 AND OUTPUT WITH THE SETTINGS FOR EST ((ENDOSCOPIC SPHINCTEROTOMY) THAT ARE USUALLY USED IN HOSPITALS, AND IT WAS STATED THAT THE SETTINGS HAVE NOT BEEN CHANGED. THE DEVICE WAS REPLACED WITH SIMILAR EQUIPMENT AND THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313825 SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-V411M-0725 1YK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VIO3 ELECTROSURGICAL UNIT