BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16110327 · Received January 5, 2023

    Report

    Report Number
    9610877-2023-50038
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 14, 2022
    Report Date
    January 6, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333234066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EC34-I10TL-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K180285. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OBJECTIVE LENS UNIT CLOUDY (NOT CLEAR VIEW). BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE MOISTURE CONDENSATION IN THE OBJECTIVE LENS UNIT. IN ADDITION, WE CONFIRMED THAT THE OPERATION CHANNEL LEAK; HOWEVER, IT IS NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT ""HR-RPT-0586 (IMAGE FAILURE)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (CLOUDY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391913 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC34-I10TL 04961333234066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown