BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE BRONCHOVIDEOSCOPE

    MDR report key: 21428876 · Received February 20, 2025

    Report

    Report Number
    9610595-2025-01809
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 23, 2025
    Report Date
    February 20, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: ELECTRICAL COMPONENT FAILED RESULTING IN IMAGE LOSS. HOWEVER, A 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 THAT DURING THE DEVICE EVALUATION, THE CHARGED COUPLED DEVICE (CDD) OF THE BRONCHOVIDEOSCOPE WAS DAMAGED AND RESULTED IN IMAGE NOT DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621205 EVIS LUCERA ELITE BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-Q290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown