BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 20514512 · Received October 23, 2024

    Report

    Report Number
    3002808148-2024-10332
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    December 6, 2022
    Report Date
    October 23, 2024
    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

    THIS REPORT IS TO PROVIDE INFORMATION BASED ON THE RESULTS OF THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE REPORTED EVENT WAS IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER SEVEN YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE E227 OCCURRED DUE TO A SCOPE IDENTIFICATION DATA ERROR, HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOFIBERVIDEOSCOPE EXHIBITED AN E227 ERROR, WHICH RESULTS IN A LOSS OF IMAGE, DUE TO A SCOPE IDENTIFICATION DATA ERROR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361682 EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC260FW

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown