BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 10268989 · Received July 14, 2020

    Report

    Report Number
    8010047-2020-04337
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 11, 2020
    Report Date
    October 14, 2020
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE DEVICE, BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. SINCE THE DEVICE WAS NOT RETURNED, THE EXACT CAUSE WAS UNKNOWN; HOWEVER, THE FOLLOWING WAS SUPPOSED TO BE THE CAUSE. THE BRIGHTNESS ADJUSTMENT FUNCTION CONTROL UNIT OF THE DEVICE WAS BROKEN. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING THE PREPARATION FOR AN UNSPECIFIED PROCEDURE USING THE SUBJECT DEVICE AND TJF-180V, BRIGHTNESS ADJUSTMENT FUNCTION DIDN'T WORK AND LIGHT WAS TOO BRIGHT. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736994 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190

    Patients

    Seq Age Sex Outcome Treatment
    1