BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 24817826 · Received April 8, 2026

    Report

    Report Number
    3002808148-2026-10335
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    November 28, 2025
    Report Date
    April 8, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: PROBE SURFACE IS CHIPPED, EDGE LOST ADHESIVE DUE TO STRESS PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHO FIBER VIDEOSCOPE EXHIBITED PROBE SURFACE IS CHIPPED AND EDGE LOST ADHESIVE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496987 EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC260FW

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown