BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12236984 · Received July 28, 2021

    Report

    Report Number
    9610877-2021-10118
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    May 21, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    UDI-DI
    04961333225262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS CAUSED DUE TO DUST INSIDE THE UNIT. IN ADDITION, WE CONFIRMED THAT THE SCOPE CONNECTOR UNIT BREAK AND THE POWER SUPPLY UNIT MALFUNCTION; HOWEVER, THESE ARE NOT RELATED TO THE ALLEGED COMPLAINT. 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. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED DURING USE. THERE WAS NO REPORT OF PATIENT HARM. (B)(6) 2021 ERROR MESSAGE 03-4000 TROUBLE OCCURRED WHEN ENTERING THE AUXILIARY LIGHT WHILE USING THE INSPECTION. SUBSTITUTE REPLACEMENT IS CARRIED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133656 PENTAX VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-3000 04961333225262

    Patients

    Seq Age Sex Outcome Treatment
    1