BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE

    MDR report key: 22960308 · Received September 4, 2025

    Report

    Report Number
    3002808148-2025-14600
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 26, 2025
    Report Date
    November 21, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    PMA / PMN Number
    K183525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    CORRECTION TO H6 CODING: DUPLICATES SUBMITTED IN ERROR ON THE ORIGINAL MDR SUBMISSION HEALTH CODE: E2403. HEALTH EFFECT: F26. MEDICAL DEVICE PROBLEM CODE: A040101. UPDATED: B5, D8, H2, H3, H6, H11. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. THE CUSTOMERS¿ ALLEGATION WAS CONFIRMED. IN ADDITION, THE INVESTIGATION FOUND THAT THE REPORTED MALFUNCTION WAS DUE TO BREAKAGE OF THE IMAGE GUIDE (IG) BUNDLE, THE IMAGE IS NOT DISPLAYED, (IT MAY RETURN TO NORMAL AT TIMES). BASED ON THE RESULTS OF THE INVESTIGATION, IT IS MOST LIKELY THE REPORTED MALFUNCTION PROBABLE CAUSES WERE SUCH AS DAMAGE OF PARTS DUE TO DETERIORATION/ LEAKAGE/ SOME KIND OF PHYSICAL STRESS, WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A BROKEN LIGHT SOURCE. THERE ARE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    NO NEW INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335595 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC190F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown