BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12230302 · Received July 27, 2021

    Report

    Report Number
    9610877-2021-10582
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    February 9, 2021
    Report Date
    July 27, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS CAUSED DUE TO A CONDENSATION OF MOISTURE IN THE CCD UNIT BY CHANGING THE TEMPERATURE OUTSIDE OF THE ENDOSCOPE. THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS NOT MARKETED IN US, THEREFORE 510K IS NOT APPLICABLE. MODEL EC38I10L US K131855 IS AVAILABLE IN THE USA WITH A 510K NUMBER K131855. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FOGGY IMAGE, MAGENTA COLORED, SPOTS IN THE IMAGE. NO PICTURES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125462 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10CF2

    Patients

    Seq Age Sex Outcome Treatment
    1