BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 24858438 · Received April 13, 2026

    Report

    Report Number
    3002808148-2026-10993
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    November 18, 2025
    Report Date
    April 13, 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

    A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY STRESS LED TO COMPONENT FAILURE. 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 BRONCHOFIBERVIDEOSCOPE EXHIBITED MISSING ADHESIVE AND WAS SLIGHTY CHIPPED ON THE EDGE OF THE PROBE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629119 EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC260FW

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown