BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12573837 · Received October 4, 2021

    Report

    Report Number
    9610877-2021-01199
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 9, 2021
    Report Date
    October 4, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE CAUSE IS THAT THE AIR CONTAINING MOISTURE THAT HAS ENTERED THE OBJECTIVE LENS / LED CONDENSES DUE TO TEMPERATURE CHANGES AND CAUSES FOGGING. THIS DEVICE IS NOT MARKETED IN US, THEREFORE 510K IS NOT APPLICABLE. MODEL EC38-I10L-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131855.

    Description of Event or Problem · 0

    THE FOGGY WAS IN MIDDLE OF THE IMAGE. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471494 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10CF

    Patients

    Seq Age Sex Outcome Treatment
    1