BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12849988 · Received November 21, 2021

    Report

    Report Number
    9610877-2021-01642
    Event Type
    Malfunction
    Date Received
    November 21, 2021
    Date of Event
    November 17, 2021
    Report Date
    November 21, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL EG29-I10C-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. EVALUATION SUMMARY: THE CAUSE IS THAT THE AIR CONTAINING MOISTURE THAT HAS ENTERED THE OBJECTIVE LENS / LED CONDENSES DUE TO TEMPERATURE CHANGES AND CAUSES FOGGING.

    Description of Event or Problem · 0

    FOGGY IMAGE. 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
    1747548 PENTAX IMAGINA GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10C 04961333237586

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown