BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 16616335 · Received March 24, 2023

    Report

    Report Number
    3002808148-2023-02980
    Event Type
    Malfunction
    Date Received
    March 24, 2023
    Report Date
    May 4, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170298868
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE PHENOMENON WAS REPRODUCED, AND SINCE IT WAS IMPROVED BY REPLACING THE LAMP, IT WAS DETERMINED THAT THE PROBLEM OCCURRED DUE TO THE FAILURE OF THE LAMP ITSELF OR THE LIFE OF THE LAMP. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN CLOSE TO 9 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING RELATED VERBIAGE WHICH COULD HAVE PREVENTED THE PHENOMENON: ¿EVIS EXERA III HIGH BRIGHTNESS LIGHT SOURCE/OLYMPUS CLV-190: <4.5 CHECKING THE LAMP USAGE TIME> CHECK THE LAMP OPERATING TIME DISPLAY ON THE OPERATION PANEL. IF "500H" IN THE LAMP USAGE TIME DISPLAY LIGHTS UP, REPLACE IT WITH A NEW ILLUMINATION LAMP ACCORDING TO "CHAPTER 6 REPLACING THE ILLUMINATION LAMP". <4.6 CHECKING ILLUMINATION LIGHT> CHECK THAT THE ILLUMINATION LIGHT IS EMITTED FROM THE TIP OF THE ENDOSCOPE. "500H" IN THE LAMP USAGE TIME DISPLAY. IF YOU FEEL THAT IT IS DARK EVEN THOUGH IT IS NOT LIT, FOLLOW THE INSTRUCTIONS IN "CHAPTER 6 REPLACING THE ILLUMINATION LAMP" TO REPLACE IT WITH A NEW ILLUMINATION LAMP. REPLACE IT WITH A NEW ONE. <6.1 OVERVIEW AND PRECAUTIONS FOR REPLACING THE ILLUMINATION LAMP> USE THE FOLLOWING LIGHTING LAMPS SPECIFIED BY OUR COMPANY FOR REPLACEMENT. XENON LAMP MAJ-1817 (MANUFACTURED BY OLYMPUS). IF YOU NEED A NEW ILLUMINATION LAMP, PLEASE CONTACT OLYMPUS.¿. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION, AS A BULB REPLACEMENT RECTIFIED THE REPORTED ISSUE. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA III XENON LIGHT SOURCE IS DISPLAYING AN E102 ERROR AND SHUTS THE UNIT OFF. THERE WAS NO PROCEDURAL DELAY, THE PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT. NO PATIENT HARM WAS REPORTED. THE CUSTOMER FURTHER REPORTED THAT THE REPORTED PHENOMENON OCCURRED FIVE TIMES. A GENERAL LOCALIZED PAIN RELIEF WAS USED, WHICH IS PART OF THE NORMAL CASE, AND WAS NOT A RESULT OF THE REPORTED MALFUNCTION. THE PATIENT WAS NOT UNDER ANESTHESIA. THE FOLLOWING RELATED PATIENT IDENTIFIERS WERE CREATED TO SPECIFICALLY ACCOUNT FOR THE NUMBER OF CASES MENTIONED ABOVE: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521682 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 MAJ-1817 XENON LAMP