BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 21970832 · Received May 6, 2025

    Report

    Report Number
    9610595-2025-07867
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    February 17, 2025
    Report Date
    June 13, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE FINAL INVESTIGATION. UPDATED FIELDS: D4, D8, H6, H11. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MOST PROBABLE CAUSE WAS NO PROBLEM DETECTED SINCE NO MALFUNCTIONS OF THE SUBJECT DEVICE HAVE BEEN REPORTED, A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE HEALTH HAZARDS COULD NOT BE ESTABLISHED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. THE LITERATURE ARTICLE DOI: 10.1177/17562848251319809 PROVIDED FOR ADDITIONAL INFORMATION. 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 CUSTOMER.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY AND SAFETY OF SEQUENTIAL CUTTING OF NASOBILIARY TUBES AS AN ALTERNATIVE TO STENT PLACEMENT AFTER NASOBILIARY DRAINAGE FOR THE TREATMENT OF HILAR MALIGNANT BILIARY STRICTURE: A RETROSPECTIVE COHORT STUDY¿. THIS STUDY AIMED TO EVALUATE THE EFFICACY AND SAFETY OF NASOBILIARY TUBE CUTTING AFTER NASOBILIARY DRAINAGE VERSUS CONVENTIONAL STENT PLACEMENT IN REDUCING POSTOPERATIVE CHOLANGITIS IN PATIENTS WITH HILAR MALIGNANT BILIARY STRICTURES. METHODS: FROM 2015 TO 2023, 208 PATIENTS WERE DIVIDED INTO TWO GROUPS: NASOBILIARY TUBE CUTTING GROUP (N = 103) AND CONVENTIONAL STENT GROUP (N = 105). THE PRIMARY OUTCOME WAS POSTOPERATIVE CHOLANGITIS, WITH SECONDARY OUTCOMES INCLUDING DRAINAGE SUCCESS, BILIRUBIN REDUCTION, RE-INTERVENTIONS, COMPLICATIONS, AND HOSPITAL STAY. RESULTS: CHOLANGITIS OCCURRED IN 11.7% OF THE NASOBILIARY TUBE CUTTING GROUP AND 26.7% OF THE CONVENTIONAL STENT GROUP (P = 0.006). SUCCESSFUL DRAINAGE WAS ACHIEVED IN 84 PATIENTS (81.6%) IN THE NASOBILIARY TUBE CUTTING GROUP AND 78 PATIENTS (74.3%) IN THE CONVENTIONAL STENT GROUP, WITH NO STATISTICALLY SIGNIFICANT DIFFERENCE (P = 0.207). PATIENTS WHOSE TOTAL BILIRUBIN REDUCTION >50% WITHIN 7 DAYS WERE SIGNIFICANTLY HIGHER IN THE NASOBILIARY TUBE CUTTING GROUP (48.5% VS 27.6%, P = 0.002). THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE GROUPS IN THE NUMBER OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURES OR RE-INTERVENTIONS REQUIRED (P > 0.05). EXCEPT FOR POSTOPERATIVE CHOLANGITIS, OTHER POSTOPERATIVE COMPLICATIONS WERE COMPARABLE BETWEEN THE GROUPS (P > 0.05). THE POSTOPERATIVE HOSPITAL STAY WAS SIGNIFICANTLY LONGER IN THE NASOBILIARY TUBE CUTTING GROUP, WITH A MEDIAN DURATION OF 10.0 (7.0, 14.0) DAYS COMPARED TO 7.0 (5.5, 12.5) DAYS IN THE CONVENTIONAL STENT GROUP (P = 0.024). BISMUTH-CORLETTE TYPE IV WAS IDENTIFIED AS AN INDEPENDENT RISK FACTOR FOR CHOLANGITIS (OR = 3.207, 95%CI: 1.253¿8.210, P = 0.015). CONCLUSION: FOR PATIENTS WITH HILAR MALIGNANT BILIARY STRICTURE, SEQUENTIAL CUTTING OF NASOBILIARY TUBES AS AN ALTERNATIVE TO STENT PLACEMENT AFTER NASOBILIARY DRAINAGE MAY REDUCE THE INCIDENCE OF POSTOPERATIVE CHOLANGITIS AND ACHIEVE EARLY SUCCESSFUL DRAINAGE, BUT IT MAY RESULT IN A PROLONGED POSTOPERATIVE HOSPITAL STAY. BISMUTH-CORLETTE TYPE IV IS AN INDEPENDENT RISK FACTOR FOR THE DEVELOPMENT OF POSTOPERATIVE CHOLANGITIS. ¿TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. [NASOBILIARY TUBE CUTTING GROUP]. POSTOPERATIVE CHOLANGITIS - 12 PATIENTS. POST-ERCP PANCREATITIS - 16 PATIENTS. HYPERAMYLASEMIA - 9 PATIENTS. ACUTE CHOLECYSTITIS - 1 PATIENT. GASTROINTESTINAL HEMORRHAGE - 2 PATIENTS. [CONVENTIONAL STENT GROUP]. POSTOPERATIVE CHOLANGITIS - 28 PATIENTS. POST-ERCP PANCREATITIS - 16 PATIENTS. HYPERAMYLASEMIA - 14 PATIENTS. ACUTE CHOLECYSTITIS - 1 PATIENT. GASTROINTESTINAL HEMORRHAGE - 5 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67729 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown JHY-FG-23- 180-A6 NON-OLYMPUS