BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 21759509 · Received April 3, 2025

    Report

    Report Number
    9610877-2025-51518
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 3, 2025
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 CLOUDY (NOT CLEAR VIEW). BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE MOISTURE CONDENSATION IN THE CCD MODULE WITH DRIVE PCB. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE U/D KNOB BROKEN, THE INSERTION FLEXIBLE TUBE BUCKLED, THE LIGHT GUIDE CABLE FOR CONTROL BODY BUCKLED, THE REMOTE CONTROL BUTTONS CRACKED, THE REMOTE CONTROL BUTTONS LEAK, AND THE LCB (LIGHT CARRYING BUNDLE) DEFECTIVE; 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 (CLOUDY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732060 PENTAX VIDEO LARYNGOSTROBOSCOPE (90 SERIES) EQL HOYA CORPORATION PENTAX TOKYO OFFICE VLS-1190STK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown