BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 23399697 · Received October 28, 2025

    Report

    Report Number
    9610877-2025-53772
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 15, 2025
    Report Date
    October 28, 2025
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    PMA / PMN Number
    K921707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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) FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE CFB (COHERENT FIBER BUNDLE). IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE CONTROL BODY FLUID DAMAGE, THE LIGHT GUIDE CABLE FOR PRONG COATING DAMAGE, THE INSERTION FLEXIBLE TUBE PERFORATED, THE BIOPSY INLET T-PIECE DIRTY; 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(FLUID DAMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2794421 PENTAX FIBER NASO PHARYNGO LARYNGO SCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE FNL-15RP3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown