BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222421 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10172
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    May 12, 2021
    Report Date
    July 24, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333248483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG29-I10C IS AVAILABLE IN THE USA WITH A 510K NUMBER K131902. EVALUATION SUMMARY: IT WAS CAUSED DUE TO AN EXCESSIVE FORCE APPLIED ON THE WATER JET TUBE AND A FLUID DAMAGE IN THE CMOS MODULE. 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 USE. THERE WAS NO REPORT OF PATIENT HARM. THE IMAGE IS FOGGY, MISTY; THE JET CHANNEL IS LEAKY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119689 PENTAX IMAGINA GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10C 04961333248483

    Patients

    Seq Age Sex Outcome Treatment
    1