BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12734809 · Received November 2, 2021

    Report

    Report Number
    9610877-2021-50225
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 21, 2021
    Report Date
    November 2, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    UDI-DI
    04961333239436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG38-J10UT-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K200090. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD IMAGE FAILURE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO A LEAKAGE OCCURRED IN THE CCD DRIVE PCB. BASED ON THE TECHNICAL REPORT, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 1

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634496 PENTAX DIGITAL LINEAR ULTRASOUND SCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG38-J10UT 04961333239436

    Patients

    Seq Age Sex Outcome Treatment
    1