BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12253537 · Received July 30, 2021

    Report

    Report Number
    9610877-2021-00427
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    April 16, 2021
    Report Date
    July 30, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PENTAX MEDICAL BECAME AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN (B)(6) STATING, "AFTER THE DEVICE WAS TURNED ON, THE POWER INDICATOR BLINKED AND THE BULB DARKENED" INVOLVING PENTAX MODEL EPK-3000-US/SERIAL (B)(4). NO FURTHER INFORMATION WAS PROVIDED. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151944 PENTAX VIDEO PROCESSOR PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-3000

    Patients

    Seq Age Sex Outcome Treatment
    1