BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 11963859 · Received June 9, 2021

    Report

    Report Number
    8010047-2021-07280
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    April 8, 2021
    Report Date
    June 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

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION. 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 · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE PREPARATION FOR USE, SCOPE COMMUNICATION ERROR B30 OCCURRED AND NO IMAGE WAS DISPLAYED WHEN CONNECTING 190 SERIES SCOPES. WHEN OTHER SERIES 180/170/150 SCOPES WERE CONNECTED, IT WORKED. AFTER CLEANING THE ELECTRICAL CONTACT POINT OF CLV-190 AND MAJ-1933 CABLE, THERE WAS NO ERROR MESSAGE BUT IMAGE WAS DISTORTED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861728 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190

    Patients

    Seq Age Sex Outcome Treatment
    1