BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 24695615 · Received March 26, 2026

    Report

    Report Number
    9610877-2026-50664
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 19, 2026
    Report Date
    March 26, 2026
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    PMA / PMN Number
    K172156
    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 CCD MODULE WITH DRIVE PCB BLACKOUT. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE WITH DRIVE PCB. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE INSERTION FLEXIBLE TUBE COATING DAMAGE, THE LIGHT GUIDE CABLE COATING DAMAGE, THE LIGHT GUIDE CABLE FOR CONTROL BODY COATING DAMAGE, THE LIGHT GUIDE CABLE FOR PRONG COATING DAMAGE, THE ANGLE LEVER TRIM CAP MISSING, THE REMOTE CONTROL BUTTONS WORN OUT, AND THE CCD SIGNAL WIRE RUPTURE; 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. VIDEO IMAGE FAILURE (BLACKOUT ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599165 PENTAX VIDEO NASO PHARYNGO LARYNGOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL8-J10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown