BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 17582008 · Received August 21, 2023

    Report

    Report Number
    9610877-2023-57726
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 21, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL FB-15V IS AVAILABLE IN THE USA WITH A 510K NUMBER K951199. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OCULAR CLOUDY (NOT CLEAR VIEW). BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE MOISTURE CONDENSATION IN THE OCULAR. BASED ON THE TECHNICAL REPORT AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (CLOUDY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687044 PENTAX FIBEROPTICCYSTOSCOPE 2.1C 4.9TP 400L ROP FAJ HOYA CORPORATION PENTAX TOKYO OFFICE FCY-15RBS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown