BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE BRONCHOVIDEOSCOPE

    MDR report key: 24103365 · Received January 16, 2026

    Report

    Report Number
    9610595-2026-05656
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    January 2, 2026
    Report Date
    February 11, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELD: B5 - DESCRIBE EVENT OR PROBLEM UPDATED TO ADD THE COMMON DEVICE NAME. H6: MEDICAL DEVICE PROBLEM CODE WAS CHANGED TO A090203 - ERRATIC OR INTERMITTENT DISPLAY THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE NOISY IMAGE MALFUNCTION: CORROSION AND AN ELECTRICAL/ELECTRONIC COMPONENT PROBLEM; EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT DURING SET UP / INSPECTION FOR USE, THE SUBJECT BRONCHOVIDEOSCOPE HAD INTERFERENCE LINES. THERE WAS NO HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SET UP / INSPECTION FOR USE, THE SUBJECT SCOPE/PROBE DEVICE HAD INTERFERENCE LINES. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165413 EVIS LUCERA ELITE BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-P290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown