BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12257126 · Received July 31, 2021

    Report

    Report Number
    9610877-2021-10686
    Event Type
    Malfunction
    Date Received
    July 31, 2021
    Date of Event
    December 7, 2020
    Report Date
    July 31, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333247455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS CAUSED DUE TO A MALFUNCTION ON THE CCD. IT IS RANDOM FAILURE. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL ED34-I10T2-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K192245. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    A BRIGHT SPOT FOUND ON THE IMAGE DURING INSTALLATION RIGHT AFTER UNBOXING THE SCOPE. 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
    1154297 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T2 04961333247455

    Patients

    Seq Age Sex Outcome Treatment
    1