BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12236976 · Received July 28, 2021

    Report

    Report Number
    9610877-2021-00351
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    June 28, 2021
    Report Date
    July 28, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-1000-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K934918. EVALUATION SUMMARY IT WAS CAUSED DUE TO THE MALFUNCTION ON THE POWER SUPPLY UNIT.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THE LIGHT SOURCE WAS WEAK AND COULD NOT GO ON OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133605 PENTAX VIDEO PROCESSOR FET HOYA CORPORATION PENTAX TOKYO OFFICE EPK-P(C)

    Patients

    Seq Age Sex Outcome Treatment
    1