BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 22929334 · Received August 29, 2025

    Report

    Report Number
    9614641-2025-01465
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    February 10, 2020
    Report Date
    January 6, 2026
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    PMA / PMN Number
    K950166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE AUTHOR. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: H6. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MOST PROBABLE CAUSE WAS NOT ESTABLISHED; THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2025-00238. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). SINCE THE LITERATURE DESCRIBED "CLEVERCUT3V SPHINCTEROTOME", OLYMPUS SELECTED "KD-V411M-0725" AS A REPRESENTATIVE PRODUCT. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY OF SINGLE-OPERATOR CHOLANGIOSCOPY-GUIDED LITHOTRIPSY COMPARED WITH LARGE BALLOON SPHINCTEROPLASTY IN MANAGEMENT OF DIFFICULT BILE DUCT STONES IN A RANDOMIZED TRIAL." BACKGROUND AND AIMS: ALTHOUGH SINGLE-OPERATOR CHOLANGIOSCOPY (SOC)-GUIDED LITHOTRIPSY AND LARGE BALLOON SPHINCTEROPLASTY (LBS)-BASED TECHNIQUES ARE EFFECTIVE RESCUE MEASURES, THE IDEAL APPROACH TO MANAGEMENT OF DIFFICULT BILE DUCT STONES IS UNCLEAR. WE CONDUCTED A RANDOMIZED TRIAL TO COMPARE THE EFFECTIVENESS OF SOC-GUIDED LITHOTRIPSY AND LBS-BASED APPROACHES FOR ENDOSCOPIC MANAGEMENT OF DIFFICULT BILE DUCT STONES. METHODS: PATIENTS WITH DIFFICULT BILE DUCT STONES WHO FAILED RETRIEVAL USING BALLOON OR BASKET WERE RANDOMLY ASSIGNED TO GROUPS THAT RECEIVED SOC-GUIDED LASER LITHOTRIPSY (SOC-LL, N [33) OR LBS (N [ 33), FROM JUNE 2016 THROUGH AUGUST 2018. WHEN ASSIGNED TREATMENT WAS UNSUCCESSFUL, PATIENTS UNDERWENT MECHANICAL LITHOTRIPSY BEFORE CROSSING OVER TO THE OTHER GROUP. THE MAIN OUTCOME WAS TREATMENT SUCCESS, DEFINED AS ABILITY TO CLEAR THE DUCT IN 1 SESSION. SECONDARY OUTCOMES WERE ADVERSE EVENTS AND TREATMENT COSTS. RESULTS: A HIGHER PROPORTION OF PATIENTS IN THE SOC-LL GROUP HAD TREATMENT SUCCESS (93.9%) THAN IN THE LBS GROUP (72.7%; P [ .021). ON MULTIPLE LOGISTIC REGRESSION ANALYSIS, TREATMENT SUCCESS WAS SIGNIFICANTLY ASSOCIATED WITH USE OF SOC-LL (ODDS RATIO [OR], 8.7; 95% CI, 1.3¿59.3; P [ .026), STONE TO EXTRAHEPATIC BILE DUCT RATIO OF 1 OR LESS (OR, 28.8; 95% CI, 1.2¿687.6; P [ .038), AND LACK OF A TAPERED BILE DUCT (OR, 26.9; 95% CI, 1.3¿558.2; P [ .034). THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN GROUPS IN ADVERSE EVENTS (9.1% IN THE SOC-LL GROUP VS 3.0% IN THE LBS GROUP, P [ .61) OR OVERALL TREATMENT COST ($16,684 IN THE SOC-LL GROUP VS $10,626 IN THE LBS GROUP; P [ .097). TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS CRICOPHARYNGEAL PERFORATION (1 PATIENT) BILE PERITONITIS CAUSED BY PERFORATION IN THE DISTAL BILE DUCT AFTER LASER LITHOTRIPSY (1 PATIENT) MILD POST-ERCP PANCREATITIS (1 PATIENT) MODERATE SEVERITY POST-ERCP PANCREATITIS (1 PATIENT) CONCLUSION: IN A RANDOMIZED TRIAL OF PATIENTS WITH DIFFICULT BILE STONES THAT CANNOT BE CLEARED BY STANDARD MANEUVERS, SOC-GUIDED LITHOTRIPSY LEADS TO DUCT CLEARANCE IN A SIGNIFICANTLY HIGHER PROPORTION OF PATIENTS THAN LBS-PARTICULARLY WHEN STONE SIZE EXCEEDS THE DIAMETER OF THE EXTRAHEPATIC BILE DUCT. ADJUNCT LITHOTRIPSY MIGHT BE REQUIRED IN PATIENTS WITH TAPERED DISTAL BILE DUCT, BECAUSE LBS ALONE IS LESS LIKELY TO BE SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2864631 SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME KNS AOMORI OLYMPUS CO., LTD. KD-V411M-0725 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention B-V232P-A| FG-V422PR| G-260-2545A| TJF-Q180V