BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 17811860 · Received September 25, 2023

    Report

    Report Number
    3002808148-2023-10324
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 28, 2023
    Report Date
    October 23, 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
    RI, 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. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, ROOT CAUSE AND OCCURRENCE CAUSE OF THE ¿E103 (LAMP LIGHTNING FAILURE)¿ COULD NOT BE IDENTIFIED. UPON TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER USED AN AFTERMARKET LAMP. THE ISSUE WAS OBSERVED DURING SET UP, THE BULB WAS REPLACED WITH A XENON LAMP, AND THE ISSUE WAS RESOLVED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 10 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    D2: ADDITIONAL PRODUCT CODES FDF AND FDS. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CUSTOMER REPLACED XENON LAMP AND RESOLVED THE REPORTED ISSUE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA III XENON LIGHT SOURCE WAS HAVING AN IMAGE PROCESSOR OR LIGHT SOURCE ERROR CODE E103 DISPLAYED; THE ISSUE WAS RESOLVED BY REPLACING THE LIGHT BULB. THE ISSUE WAS FOUND DURING SET UP. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241460 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