BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 23421424 · Received October 30, 2025

    Report

    Report Number
    9610877-2025-53803
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 22, 2025
    Report Date
    October 30, 2025
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    PMA / PMN Number
    K172156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 BENDING RUBBER GLUING MISSING. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE PHYSICAL DAMAGE APPLIED ON THE BENDING RUBBER GLUING. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE REMOTE CONTROL BUTTONS CUT; HOWEVER, THIS DEFECT IS NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. IN TERMS OF THE BENDING RUBBER GLUE MISSING, THE POSSIBILITY OF DROPPING INTO HUMAN BODY COULD NOT BE DENIED. MOREOVER, BASED ON THE TECHNICAL REPORT""HR-RPT-0581(BENDING RUBBER)"" 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. BENDING RUBBER PEELED OFF(BLACK GLUE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617873 PENTAX VIDEO NASO PHARYNGO LARYNGOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL11-J10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown