BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 15507263 · Received September 29, 2022

    Report

    Report Number
    9614641-2022-00381
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    August 30, 2022
    Report Date
    September 29, 2022
    Manufacturer
    AOMORI OLYMPUS CO., LTD
    Product Code
    KNS
    PMA / PMN Number
    K950166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDRESS- THE FULL NAME OF CUSTOMERS ESTABLISHMENT IS (B)(6). THE DEVICE WITH MODEL KD-V411M-0320 RETURNED FOR EVALUATION. THE LOT NUMBER WAS 1YK WITH SUPPLEMENTARY INFORMATION NUMBER OF ¿11¿. (M-BC MANUFACTURE DATE: NOV 11, 2021). INSPECTION OF THE DEVICE FOUND THE COATED PORTION OF THE CUTTING WIRE WAS TORN, AND 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. SHAPE OF THE COATED PORTION OF THE SUBJECT DEVICE WAS SIMILAR TO THE SHAPE CONFIRMED IN THE PAST INVESTIGATION RESULT. IN INVESTIGATION PERFORMED IN THE PAST, A COATED PORTION DAMAGE WAS DUPLICATED BY HEAT GENERATION DUE TO AN ELECTRICAL DISCHARGE. OTHER ABNORMALITIES THAT COULD LEAD TO THE BREAKAGE OF THE CUTTING WIRE NOT OBSERVED. REVIEW OF THE DEVICE HISTORY RECORDS (DHR¿S) FOUND NO ABNORMALITIES IN THE FOLLOWING RECORD OF THE ITEMS BELOW WHICH RELATE TO THE REPORTED PHENOMENON. PROCESS INSPECTION SHEET, QUALITY INSPECTION SHEET, NONCONFORMING PRODUCT REPORT, ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. INSTRUCTIONS FOR USE (IFU): THIS INSTRUCTION MANUAL (DRAWING NO. GK6224, REVISION NO.9) 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 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 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 (DESCRIPTION). THE DEVICE WAS NOT PROTRUDED ENOUGH FROM THE ENDOSCOPE UNTIL THE REAR END OF THE CUTTING WIRE WAS IN THE FIELD OF VIEW. DUE TO THE SITUATION OF ¿1¿ DESCRIPTION, THE CUTTING WIRE AND THE ENDOSCOPE WERE BEING CLOSE TO EACH OTHER. 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. AN ELECTRICAL DISCHARGE POSSIBLY OCCURRED, AND THE CUTTING WIRE BECAME HOT INSTANTLY. THAT MIGHT HAVE CAUSED THE CUTTING WIRE TO BREAK AND THE BURNT OF THE ENDOSCOPE. IT CAN BE INFERRED FROM THE DEVICE EVALUATION THAT HEAT GENERATED BY AN ELECTRICAL DISCHARGE CAUSED DAMAGE OF THE COATED PORTION. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, DURING THERAPEUTIC CHOLANGIOPANCREATOGRAPHY (ERCP) ENDOSCOPIC SPHINCTEROTOMY (EST) PAPILLOTOMY PROCEDURE, THE SHARPNESS SUDDENLY DETERIORATED DURING INCISION. WHEN THE USER CHECKED THE DEVICE, IT WAS DETERMINED THE KNIFE WIRE WAS CUT. THE DEVICE WAS REPLACED WITH A NEW ONE; HOWEVER, AFTER A WHILE IT STOPPED WORKING. THE USER THEN CHECKED THE DEVICE AND FOUND THE WIRE WAS CUT. THE INTENDED PROCEDURE WAS COMPLETED AFTER REPLACING WITH A THIRD ONE (SIMILAR DEVICE). ACCORDING TO THE REPORTER, IT IS UNKNOWN HOW LONG IT TOOK FOR EACH OF THE PROBLEM TO OCCUR DURING THE PROCEDURE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THE HIGH FREQUENCY (HF) DEVICE USED IN THE CASE IS UNKNOWN. THE DUODENOSCOPE USED IN THE PROCEDURE AND WITH THE SUBJECT DEVICES WAS A THIRD PARTY SCOPE (FUJI FILM SCOPE). THIS EVENT INCLUDES TWO REPORTS . REPORT WITH PATIENT IDENTIFIER (B)(6) MODEL KD-V411M-0320 LOT 1YK (FIRST DEVICE USED), REPORT WITH PATIENT IDENTIFIER (B)(6) MODEL KD-V411M-0320 LOT 23K (SECOND DEVICE USED). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) KD-V411M-0320 LOT 1YK (FIRST DEVICE USED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615773 SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME KNS AOMORI OLYMPUS CO., LTD KD-V411M-0320 1YK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DUODENOSCOPE (FUJIFILM)HIGH FREQUENCY DEVICE