BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12200831 · Received July 21, 2021

    Report

    Report Number
    9610877-2021-10193
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    May 8, 2021
    Report Date
    July 21, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333224913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG-2990K IS AVAILABLE IN THE USA WITH A 510K NUMBER K131902. EVALUATION SUMMARY IT WAS CAUSED DUE TO A FLUID DAMAGE IN THE ENDOSCOPE. 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 DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM. DURING DAILY INSPECTION THE USER FOUND THAT THE SCOPE WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097816 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-290KP 04961333224913

    Patients

    Seq Age Sex Outcome Treatment
    1