BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 22312963 · Received June 24, 2025

    Report

    Report Number
    9610877-2025-52349
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    June 4, 2025
    Report Date
    June 24, 2025
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS DEVICE IS CLASS1 PRODUCT SO THAT 510K# IS BLANK. 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 LG CONNECTOR FLUID DAMAGE, THE LIGHT GUIDE CABLE FOR CONTROL BODY FLUID DAMAGE, THE LIGHT GUIDE CABLE FOR PRONG FLUID DAMAGE, THE U/D KNOB BROKEN, THE INSERTION FLEXIBLE TUBE CRUSHED, THE LIGHT GUIDE CABLE LEAK, THE INSERTION FLEXIBLE TUBE DISCOLORED, AND THE LIGHT GUIDE CABLE COLLAPSE; 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
    1997803 PENTAX VIDEO LARYNGOSTROBOSCOPE (90 SERIES) EQL HOYA CORPORATION PENTAX TOKYO OFFICE VLS-1190STK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown