BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 16028686 · Received December 21, 2022

    Report

    Report Number
    3002808148-2022-05487
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    November 16, 2022
    Report Date
    August 1, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170298868
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 9 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, AND THE INABILITY TO EVALUATE THE SUBJECT DEVICE AND DUPLICATE THE EVENT, A DEFINITIVE ROOT CAUSE OF THE E103 ERROR COULD NOT BE IDENTIFIED. HOWEVER, IT¿S LIKELY THE CAUSE IS RELATED TO AN IGNITION ERROR ASSOCIATED WITH THE FAILURE OF EITHER THE THERMAL SWITCH, MAIN BOARD, LAMP HOUSING, XENON LAMP, IGNITOR, OR POWER SUPPLY UNIT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA III VIDEO SYSTEM CENTER HAD AN INTERMITTENT E103 LAMP ERROR. THE LAMP ASSEMBLY WAS CHANGED BUT THE ISSUE PERSISTED. THE ERROR CLEARED TEMPORARILY AFTER THE POWER CYCLE WAS RESET BUT INTERMITTENTLY OCCURRED ONCE OR TWICE A MONTH. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    THE LAMP ERROR E103 OCCURRED ON NOVEMBER 16, 2022 AND NOVEMBER 18, 2022 DURING EQUIPMENT TESTING. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THE CLV-190 WAS USED ALONGSIDE THE OEP-5 AND CV-190.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630550 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-190 04953170298868

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OEP-5 AND CV-190.