BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12236981 · Received July 28, 2021

    Report

    Report Number
    9610877-2021-00361
    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
    PEA
    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 ON THE ELECTRIC PARTS IN THE PROCESSOR. 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-3000-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K172156.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, AUX LAMP IS ON. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133649 PENTAX VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-3000

    Patients

    Seq Age Sex Outcome Treatment
    1