BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12285960 · Received August 6, 2021

    Report

    Report Number
    9610877-2021-10679
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    December 23, 2020
    Report Date
    August 6, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS CAUSED DUE TO A MALFUNCTION ON THE ELECTRIC PARTS IN THE PROCESSOR. THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS NOT MARKETED IN US, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-I5010-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K182004. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    DURING USE, THE MAIN DISPLAY SCREEN WAS BLACK. 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
    1184967 PENTAX VIDEO PROCESSOR PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I5000

    Patients

    Seq Age Sex Outcome Treatment
    1