BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II XENON LIGHT SOURCE

    MDR report key: 11402583 · Received March 2, 2021

    Report

    Report Number
    8010047-2021-03229
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Report Date
    April 9, 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. THIS DEVICE WAS MANUFACTURED OVER 15 YEARS AGO, SO NO MANUFACTURING RECORDS COULD BE CONFIRMED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE INVESTIGATION RESULT, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) ASSUMED THAT THE REPORTED EVENT WAS CAUSED BY FOLLOWINGS; -THE ELECTRICAL CONTACTS OF THE SCOPE CONNECTOR SOCKET WERE NOT SUFFICIENTLY DRIED OR HAD FOREIGN MATTER ON THEM. -PHYSICAL STRESS DAMAGED THE ELECTRICAL CONTACTS OF THE SCOPE CONNECTOR SOCKET. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THEN, OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OMSI AND FOUND FOLLOWINGS; ALL THE LEDS ON THE FRONT PANEL FLASHED DUE TO HEAVY DUST ON THE SOCKET. THE SCOPE CONNECTOR SOCKET WAS DAMAGED ENOUGH TO NEED TO BE REPLACED. THERE WAS HEAVY DUST INSIDE THE DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN IDENTIFIED BY LEGAL MANUFACTURER OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THIS DEVICE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS (B)(4) PRIVATE LIMITED (OMSI) WAS INFORMED THAT THE FRONT PANEL LIGHT BLINKED CONTINUOUSLY. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294814 EVIS EXERA II XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-180

    Patients

    Seq Age Sex Outcome Treatment
    1