BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12223389 · Received July 26, 2021

    Report

    Report Number
    9610877-2021-10588
    Event Type
    Malfunction
    Date Received
    July 26, 2021
    Date of Event
    October 26, 2020
    Report Date
    July 26, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    UDI-DI
    04961333223794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS CAUSED DUE TO THE PCB BOARD FAILURE. THIS DEVICE IS NOT MARKETED IN US, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-I7010-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

    BEFORE THE INSTALLATION, FSE FOUND THAT THE PROCESSOR CAN'T RECOGNIZE THE SCOPE AND APPEARED THE ERROR CODE: NO. 12 WHEN THEY DID THE OPEN BOX INSPECTION. THE TIME OF EVENT IS BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121455 PENTAX OPTIVISTA HD VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I7010 04961333223794

    Patients

    Seq Age Sex Outcome Treatment
    1