BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16758945 · Received April 18, 2023

    Report

    Report Number
    9610877-2023-53614
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 20, 2023
    Report Date
    April 18, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    GCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 EE-1580K IS AVAILABLE IN THE USA, WITH A 510K NUMBER K961564. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED, THAT THE CCD MODULE WITH DRIVE PCB BLACKOUT. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED, DUE TO THE PHYSICAL DAMAGE APPLIED ON THE CCD MODULE WITH DRIVE PCB. 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 NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624110 PENTAX VIDEO ESOPHAGOSCOPE GCL HOYA CORPORATION PENTAX TOKYO OFFICE EE17-J10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown