BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE BRONCHOVIDEOSCOPE

    MDR report key: 23330868 · Received October 17, 2025

    Report

    Report Number
    9610595-2025-26588
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 17, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    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. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION PROVIDED, IT IS LIKELY DUE TO SOME KIND OF STRESS SUCH AS DAMAGE OR DETERIORATION OF PARTS. THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. THE ROOT CAUSE COULD NOT BE IDENTIFIED. 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 DURING THE DEVICE INSPECTION THAT SUBJECT DEVICE HAD THE ADHESIVE ON THE LIGHT GUIDE LENS COME OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541852 EVIS LUCERA ELITE BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-P290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown