BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222438 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10261
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    April 22, 2021
    Report Date
    July 24, 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

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-I7010-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K182004. EVALUATION SUMMARY: IT WAS CAUSED DUE TO A MALFUNCTION ON THE PCB IN THE EPK-I7010. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. ON THE INSTALLATION DAY, THE ERROR CODE APPEARED. FSE TRIED TO POWER ON THE PROCESSOR REPEATEDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119723 PENTAX OPTIVISTA HD VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I7010 04961333223794

    Patients

    Seq Age Sex Outcome Treatment
    1