BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 12224189 · Received July 26, 2021

    Report

    Report Number
    8010047-2021-09325
    Event Type
    Malfunction
    Date Received
    July 26, 2021
    Date of Event
    July 1, 2021
    Report Date
    September 21, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE WAS EVALUATED AT OLYMPUS MEDICAL SYSTEMS INDIA PRIVATE LIMITED (OMSI). AS A RESULT OF THE EVALUATION, THE FOLLOWING WAS CONFIRMED. -DUST IN THE OUTPUT SOCKET CAUSED ALL THE LEDS ON THE FRONT PANEL TO FLASH AND DISPLAY CLV SCOPE ERROR E300. ERROR CODE E300 MEANS THAT THE ENDOSCOPE IS CONNECTED INCORRECTLY. AFTER REMOVING THE DUST, THE DEVICE WORKED FINE. -THE CHASSIS WAS HEAVILY RUSTED. -THERE WAS A LOT OF DUST INSIDE THE DEVICE. -THE FRONT PANEL CHASSIS WAS HEAVILY RUSTED. SINCE THE PHENOMENON WAS RESOLVED BY REMOVING THE DUST FROM THE OUTPUT SOCKET FROM THE EVALUATION RESULT OF THE DEVICE, IT IS POSSIBLE THAT THE LEDS ON THE FRONT PANEL FLASHED DUE TO POOR COMMUNICATION WITH THE ENDOSCOPE DUE TO THE EFFECT OF DUST ADHESION. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE INSTRUCTION MANUAL PROHIBITS THE USE OF THE DEVICE IN A DUSTY ENVIRONMENT. BY FOLLOWING THIS INSTRUCTION, IT MAY HAVE BEEN POSSIBLE TO PREVENT THE OCCURRENCE OF THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS PLANNED TO BE RETURNED TO OLYMPUS MEDICAL SYSTEMS (B)(4) PRIVATE LIMITED BUT HAS NOT BEEN RETURNED YET. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY A TECHNICIAN THAT DURING THE PREPARATION FOR USE, THE LIGHT GUIDE CONNECTION ERROR E304 OCCURRED AND THE LED ON THE FRONT PANEL FLASHED INTERMITTENTLY. ERROR CODE E304 MEANS THAT THE OUTPUT CONNECTOR OF THE VIDEO SYSTEM CENTER IS NOT CONNECTED CORRECTLY. IN ADDITION, DUST HAD ACCUMULATED HEAVILY INSIDE THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122225 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190

    Patients

    Seq Age Sex Outcome Treatment
    1