BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 17101004 · Received June 9, 2023

    Report

    Report Number
    2429304-2023-00185
    Event Type
    Injury
    Date Received
    June 9, 2023
    Date of Event
    May 12, 2023
    Report Date
    June 9, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170298868
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS NO AIR AND AN INTERMITTENT BLACK SCREEN ON THE EVIS EXERA III XENON LIGHT SOURCE DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WAS NO ERROR MESSAGE OBSERVED AS A RESULT OF THE FAILURE. THE PROCEDURE WAS MOVED TO THE NEXT ROOM TO USE A DIFFERENT WM-DP2 WORKSTATION SET AND LATER, THE LIGHT SOURCE AND EVIS EXERA III VIDEO SYSTEM CENTER WERE PLUGGED INTO THE WALL AND STARTED WORKING. THE CONDITION OF THE PATIENT WAS NOT IMPACTED BY THE FAILURE AND THE PROBLEM DID NOT AFFECT THE OUTCOME OF THE PROCEDURE. HOWEVER, THE PROCEDURE WAS DELAYED THIRTY MINUTES TO TROUBLESHOOT. NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED PROBLEM. NO ADDITIONAL PATIENT HARM WAS REPORTED. THE FOLLOWING MEDWATCH REPORTS ARE RELATED: PATIENT IDENTIFIERS (B)(6) (WM-DP2 WORKSTATION SET) AND (B)(6)(EVIS EXERA III XENON LIGHT SOURCE - THIS REPORT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136124 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 Other CV-190 EVIS EXERA III VIDEO SYSTEM CENTER.| WM-DP2 WORKSTATION SET SN: (B)(6).