BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 23744957 · Received December 8, 2025

    Report

    Report Number
    3002808148-2025-24501
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 14, 2025
    Report Date
    April 6, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170298868
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION AND DUE TO A CORRECTION REQUIRED. UPDATED FIELDS: G3, G6, H2, H4, H6 AND H11, CORRECTION: H6 HEALTH EFFECT IMPACT CODE. THE CUSTOMER CONTACTED OLYMPUS TECHNICAL ASSISTANCE SUPPORT VIA PHONE. THE CUSTOMER CLEANED THE ONE TOUCH CONNECTOR ON LOANER PCF-H190L, 2200047 WITH A LINT-FREE ALCOHOL PREP PAD. SHE OBSERVED THAT THE ONE TOUCH CONNECTOR CONTACTS ON LOANER PCF-H190L, 2200047 APPEAR SLIGHTLY SCRATCHED ON CLOSE EXAMINATION. SHE ALSO OPTED TO BLOW COMPRESSED AIR INTO THE SOCKET OF CLV-190 / 7660070 TO POSSIBLY DISLODGE DUST. THE ERROR CODE APPEARED INTERMITTENTLY UPON SUBSEQUENT INSERTIONS. OLYMPUS TECHNICAL ASSISTANCE SUPPORT EXPLAINED THAT IT IS POSSIBLE THAT CLV-190, 7660070¿S SOCKET MAY BE WORN OUT AND RECOMMENDED SENDING THE UNIT TO OLYMPUS REPAIR FOR EVALUATION. THE CUSTOMER INFORMED OLYMPUS TECHNICAL ASSISTANCE SUPPORT OF THE EVENT. THE DEVICE WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION A ROOT CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE XENON LIGHT SOURCE DISPLAYED ERROR CODES B30. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143617 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-190 04953170298868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown