BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12629062 · Received October 13, 2021

    Report

    Report Number
    9610877-2021-01123
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 27, 2021
    Report Date
    December 24, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333237586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG29-I10C-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD IMAGE FAILURE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE LEAKAGE OCCURRED IN THE CCD MODULE. IN ADDITION, WE CONFIRMED THAT THE AIR/WATER NOZZLE CLOGGED; HOWEVER, IT IS NOT RELATED TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT, IT WAS EVALUATED TO SUBMIT MDR.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG29-I10C-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    FOGGY, MISTY IMAGE. MOISTURE UNDER LED COVER GLASSES. CONNECTION BETWEEN SEGMENT AND IFT LOOSENED, SCREWS MISSING. A/W SOCKET LOOSENED. THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520335 PENTAX IMAGINA GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10C 04961333237586

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown