BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12834097 · Received November 18, 2021

    Report

    Report Number
    9610877-2021-50360
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Date of Event
    November 5, 2021
    Report Date
    November 18, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    UDI-DI
    04961333239436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 DRIVER PCB DEFECTIVE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD DRIVER PCB. 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
    1733642 PENTAX DIGITAL LINEAR ULTRASOUND SCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG38-J10UT 04961333239436

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown