BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 12201337 · Received July 21, 2021

    Report

    Report Number
    8010047-2021-09166
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Report Date
    July 21, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K122831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), BUT RETURNED TO OLYMPUS REPAIR CENTER FOR EVALUATION. ACCORDING TO THE EVALUATION, THE FOLLOWING WAS FOUND. WHITE LIGHT WAS VERY LESS DUE TO A FAILURE OF THE LED UNIT. THERE WAS RUST ON THE TOP COVER. POWER SWITCH MADE A NOISE. 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

    THE USER FOUND THAT THE LIGHT INTENSITY OF THE MAIN LAMP WAS TOO LOW. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102447 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-170

    Patients

    Seq Age Sex Outcome Treatment
    1