BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II XENON LIGHT SOURCE

    MDR report key: 15523973 · Received October 1, 2022

    Report

    Report Number
    3002808148-2022-02648
    Event Type
    Injury
    Date Received
    October 1, 2022
    Date of Event
    September 3, 2021
    Report Date
    November 3, 2022
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170215544
    PMA / PMN Number
    K133538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND THE RESULTS OF THE DEVICE HISTORY RECORDS (DHR) REVIEW. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: H4, H6, H10. THE DHR FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER COULD NOT DETERMINE THE PROBABLY CAUSE, THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    HEALTH CANADA INFORMED OLYMPUS OF THE FOLLOWING REPORT RECEIVED BY HEALTH CANADA ON 15SEP2021, HEALTH CANADA REFERENCE #(B)(4), LRN-20210917-1939, RCT-20210917-3141: THE CUSTOMER REPORTED TO HEALTH CANADA, A PATIENT WAS TRANSFERRED TO THE ICU FROM THE WARD RECEIVING OXYGENATION FROM A NON-OLYMPUS OPTIFLOW. THE SURGEON PERFORMED A BRONCHOSCOPY TO REMOVE A MUCOUS PLUG TO PREVENT PATIENT INTUBATION. ABOUT FIFTEEN MINUTES INTO THE PROCEDURE, THE SUBJECT DEVICE POWER SHUT DOWN. THE SURGEON WAS UNABLE TO VISUALIZE THE ENDOSCOPE AT THIS TIME. TROUBLESHOOTING WAS PERFORMED ON THE SUBJECT DEVICE BUT NO POWER COULD BE GENERATED. THE SURGEON STOPPED THE PROCEDURE AND INTUBATED THE PATIENT WITH THE BACK-UP NON-OLYMPUS INTUBATION EQUIPMENT ON FIRST ATTEMPT. NO ADDITIONAL CONCERNS OR COMPLICATIONS REPORTED. PATIENT'S VITAL SIGNS REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479380 EVIS EXERA II XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-180 04953170215544

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O UNKNOWN ENDOSCOPE.