BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 17717100 · Received September 10, 2023

    Report

    Report Number
    9610877-2023-58800
    Event Type
    Malfunction
    Date Received
    September 10, 2023
    Date of Event
    August 30, 2023
    Report Date
    September 11, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 ED34-I10T-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K163614. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD IMAGE DISTORTION. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE. BASED ON THE TECHNICAL REPORT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891750 PENTAX VIDEO DUODENOSCOPE - I10 STANDARD FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown