BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 19768309 · Received July 17, 2024

    Report

    Report Number
    3002808148-2024-06519
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 26, 2024
    Report Date
    September 4, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    UDI-DI
    04953170356360
    PMA / PMN Number
    K070983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONAL INFORMATION ADDED TO FIELDS: D8, H3, H4 AND H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 5 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S REPORTABLE MALFUNCTION OF IMAGE LOSS WAS NOT CONFIRMED, INSTEAD A FOGGY IMAGE WAS REPRODUCED. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE WARNS THE PREVENTION METHOD ASSOCIATED WITH THE EVENT IN: INSTRUCTIONS EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180F IMPORTANT INFORMATION: PLEASE READ BEFORE USE. A. DO NOT APPLY SHOCK TO THE DISTAL END OF THE INSERTION SECTION, PARTICULARLY THE ULTRASONIC TRANSDUCER AND THE OBJECTIVE LENS SURFACE AT THE DISTAL END. VISUAL ABNORMALITIES MAY RESULT. B. DO NOT TWIST OR BEND THE BENDING SECTION WITH YOUR HANDS. EQUIPMENT DAMAGE MAY RESULT. C. DO NOT SQUEEZE THE BENDING SECTION FORCEFULLY. THE COVERING OF THE BENDING SECTION MAY STRETCH OR BREAK AND CAUSE WATER LEAKS. D. THE COVER OF THE IRRIGATION PORT PART CANNOT BE REMOVED. EQUIPMENT DAMAGE CAN RESULT. E. DO NOT HIT OR BEND THE ELECTRICAL CONTACTS ON THE ENDOSCOPE CONNECTOR. THE CONNECTION TO THE LIGHT SOURCE MAY BE IMPAIRED AND FAULTY CONTACT CAN RESULT. F. DO NOT ATTEMPT TO BEND THE ENDOSCOPE¿S INSERTION SECTION WITH EXCESSIVE FORCE. OTHERWISE, THE INSERTION SECTION MAY BE DAMAGED. G. DO NOT TOUCH THE ELECTRICAL CONTACTS IN THE ULTRASONIC CONNECTOR. EQUIPMENT DAMAGE CAN RESULT. H. DO NOT PULL, TWIST OR TIGHTLY COIL THE ULTRASONIC CABLE. NOISE CAN DEVELOP IN THE ULTRASONIC IMAGE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED A BAD IMAGE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT/USER HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362646 EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC180F 04953170356360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown