BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12602950 · Received October 10, 2021

    Report

    Report Number
    9610877-2021-01173
    Event Type
    Malfunction
    Date Received
    October 10, 2021
    Date of Event
    July 19, 2021
    Report Date
    March 15, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: WE CHECKED THE CONTINUOUS OPERATION FOR ABOUT HALF OF THE USER'S USAGE TIME (ABOUT 10 HOURS), BUT COULD NOT CONFIRM, THE REPRODUCTION OF THE FLUCTUATION OF THE LIGHT INTENSITY. WE WILL DELIVER IT AND REPLACE POSSIBLE PARTS, BECAUSE IT IS NOT REPRODUCIBLE. CORRECTION INFORMATION: H6: CODING CHANGED, BASED ON THE INVESTIGATION RESULT.

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-3000-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K172156.

    Description of Event or Problem · 0

    ON (B)(6) 2021, DURING THE MORNING MEDICAL EXAMINATION THERE WAS A PROBLEM THAT THE IMAGE SUDDENLY BECAME DARK OR SUDDENLY BRIGHTENED. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500685 PENTAX VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-3000

    Patients

    Seq Age Sex Outcome Treatment
    1