BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE BRONCHOVIDEOSCOPE

    MDR report key: 20608562 · Received November 5, 2024

    Report

    Report Number
    9610595-2024-22557
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Report Date
    December 3, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. HOWEVER, THE LIKELY CAUSE OF THE REPORTED EVENT IS DUE TO A DAMAGED IMAGE SENSOR UNIT (E.G., DISCONNECTION) OR FAILURE OF MOUNTED COMPONENTS (IC CHIP, CAPACITOR, ETC.) ON THE ELECTRICAL BOARD DUE TO STRESS FROM USE, EXTERNAL FACTORS, OR HANDLING. THE INSPECTION METHOD FOR THE SUGGESTED EVENT IS DESCRIBED AS FOLLOWS IN THE OPERATION MANUAL FOR BF-290 SERIES "CHAPTER 3 PREPARATION AND INSPECTION 3.8 INSPECTION OF THE ENDOSCOPIC SYSTEM¿. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WAS A SHORT DELAY (FIVE MINUTES)AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49741 EVIS LUCERA ELITE BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-P290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown