BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12243721 · Received July 29, 2021

    Report

    Report Number
    9610877-2021-10638
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    January 25, 2021
    Report Date
    July 29, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS CAUSED DUE TO A MALFUNCTION OF THE TOUCH PANEL ON THE PROCESSOR. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. 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, THE TOUCH PANEL SCREEN APPEARED FLICKERING UPON OPENING THE BOX. THE HOSPITAL REJECTED THE INSTALLATION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140915 PENTAX OPTIVISTA HD VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I7010 04961333223794

    Patients

    Seq Age Sex Outcome Treatment
    1