BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 23663326 · Received November 27, 2025

    Report

    Report Number
    9610877-2025-54120
    Event Type
    Malfunction
    Date Received
    November 27, 2025
    Date of Event
    November 20, 2025
    Report Date
    November 27, 2025
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL FNL-10RP3 IS AVAILABLE IN THE USA WITH A 510K NUMBER K951196. D4. UDI: "NOT DISTRIBUTED IN USA", BECAUSE PRODUCTS ARE NOT DISTRIBUTED IN USA PRODUCTS, BUT SIMILAR DEVICE PRODUCT ARE LISTED IN USA. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CFB (COHERENT FIBER BUNDLE) BROKEN. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CFB (COHERENT FIBER BUNDLE). IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE INSERTION FLEXIBLE TUBE SCRATCHED, AND THE OBJECTIVE LENS SCRATCHED; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT ""HR-RPT-0586 (IMAGE FAILURE)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (BROKEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120635 PENTAX FIBER NASO PHARYNGO LARYNGOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE FNL-10RBS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown