BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 11290626 · Received February 7, 2021

    Report

    Report Number
    8010047-2021-02315
    Event Type
    Malfunction
    Date Received
    February 7, 2021
    Report Date
    March 18, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), IT COULD NOT BE INVESTIGATED. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER BASED ON THE REPORT OF THE SERVICE DEPARTMENT OF OLYMPUS EUROPE SE & CO. KG (OEKG) WHICH HAD A PICTURE OF THE DUSTY COOLING FAN BY THE USER HANDLING, OMSC SURMISED THERE WAS THE POSSIBILITY THIS PHENOMENON WAS ATTRIBUTED TO OVERHEATING OF THE SUBJECT DEVICE WHICH WAS OCCURRED BY NOT COOLING INSIDE AND RISING INTERNAL TEMPERATURE WITH DUSTY COOLING FAN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE HAS BEEN NOT RETURNED TO OMSC FOR THE EVALUATION, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT THE EXAMINATION LAMP OF THE SUBJECT DEVICE WAS SWITCHED TO THE EMERGENCY LAMP DURING THE UNSPECIFIED PROCEDURE AFTER 1 HOUR PASSING FROM THE SUBJECT DEVICE LIGHTING ON. THE BIOMEDICAL ENGINEER AT THE USER FACILITY TRIED TO LIGHT ON THE EXAMINATION LAMP BUT COULD NOT. AT ANOTHER TIME, THE USER HAS NOTICED THE THING WHICH THE EMERGENCY LAMP LIT ON OCCURRING AFTER 1-HOUR WORK. THE USER ALSO REPORTED THAT IT SEEMED THE EXAMINATION LAMP WAS OK FOR A WHILE AND THE DEVICE WAS DUST-FREE AND THE FAN WAS WORKING CORRECTLY, AND LATER IT WAS SWITCHED TO THE EMERGENCY LAMP. THE ENGINEER OF OLYMPUS EUROPE SE & CO. KG (OEKG) CHECKED THE SUBJECT DEVICE. DURING THE DISASSEMBLY PROCEDURE OF THE SUBJECT DEVICE, AN ACCUMULATION OF DUST WAS FOUND INSIDE, ESPECIALLY ON THE BLADE COOLING FANS, WHICH WAS CAUSING THE DEVICE TO OVER-HEAT. MOREOVER, A DEFICIENCY OF THE EXAMINATION LAMP WAS IDENTIFIED THAT THE LAMP WAS A NON-OLYMPUS COMPONENT. AND THE AIR FLOW PUMP WAS LOW AND NO CHANGE IN AIR SUPPLY VOLUME WHEN SWITCHING AIR SUPPLY SETTING TO LOW, MEDIUM, AND HIGH ADDITIONALLY. THERE WAS ALSO THE BRIGHTNESS ADJUSTMENT FAILURE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187239 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190

    Patients

    Seq Age Sex Outcome Treatment
    1