BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12236983 · Received July 28, 2021

    Report

    Report Number
    9610877-2021-00376
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    May 27, 2021
    Report Date
    July 28, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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 EC38-I10L-US IS AVAILABLE IN THE USA WITHA 510K NUMBER K131855. EVALUATION SUMMARY IT WAS CAUSED DUE TO A MALFUNCTION ON THE CCD.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THE IMAGE BECAME RED AND STOPPED USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133655 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10M

    Patients

    Seq Age Sex Outcome Treatment
    1