BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE

    MDR report key: 20920957 · Received December 12, 2024

    Report

    Report Number
    3002808148-2024-38649
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 15, 2024
    Report Date
    September 9, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    UDI-DI
    04953170399831
    PMA / PMN Number
    K183525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-01038. 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

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER: 2429304-2024-01038-01 THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTION AND THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION: UPDATED FIELDS: B5, D8 G1, H2, H4 AND H6 AND H11. CORRECTIONS TO B1, B2, AND H1. THIS EVENT WAS INITIALLY CONSERVATIVELY REPORTED AS A SERIOUS INJURY; HOWEVER, THERE IS NO EVIDENCE THE PATIENT SUFFERED ANY SERIOUS INJURY OR ADVERSE EFFECTS FROM THE PROLONGED PROCEDURE. OLYMPUS MADE MULTIPLE ATTEMPTS TO RECEIVE MORE INFORMATION FROM THE CUSTOMER WITHOUT SUCCESS. THUS CORRECTING B1, B2, AND H1. B1 SHOULD NOT BE MARKED AS AN ADVERSE EVENT BUT PRODUCT PROBLEM ONLY, AND B2 SHOULD NOT BE MARKED AT ALL. H1 SHOULD ALSO NOT BE MARKED AS SERIOUS INJURY BUT MALFUNCTION INSTEAD. THE DEVICE WAS RETURNED FOR EVALUATION; THE COMPLAINT WAS CONFIRMED. THE DEVICE HAS A CONFIRMED B30 ERROR WHICH WAS RESOLVED AFTER AERATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED, HOWEVER, THE MOST PROBABLE CAUSE OF B30 ERROR WAS DUE TO COMPONENT FAILURE, WHICH 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 THE BRONCHOFIBERVIDEOSCOPE DISPLAYED NO IMAGE AND AN ERROR MESSAGE ON THE TOWER WAS OBSERVED. THIS OCCURRED DURING ENDOBRONCHIAL ULTRASOUND PROCEDURE, WHICH CAUSED PROLONGATION GREATER THAN OR EQUAL TO 30 MINUTES, WITH PATIENT UNDER SEDATION. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. AS NO ADDITIONAL INFORMATION OBTAINED, IT WAS DETERMINED THAT THERE WAS NO HARM TO THE PATIENT AS INITIALLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2417365 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC190F 04953170399831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown