BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222405 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10106
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    May 24, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-I7010 IS AVAILABLE IN THE USA WITH A 510K NUMBER K182004. EVALUATION SUMMARY: IT WAS CAUSED DUE TO A PHYSICAL DAMAGE APPLIED ON THE LAMP DOOR. 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 DELIVERY. THERE WAS NO REPORT OF PATIENT HARM. WHEN CHECKING THE INTERNAL DUST, I OPENED THE LAMP DOOR AND IT FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119643 PENTAX OPTIVISTA HD VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I7010 04961333223794

    Patients

    Seq Age Sex Outcome Treatment
    1