BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 21226570 · Received January 24, 2025

    Report

    Report Number
    9610877-2025-50467
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    January 20, 2025
    Report Date
    January 24, 2025
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EQL
    UDI-DI
    04961333226238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE CCD MODULE WITH DRIVE PCB. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE LCB (LIGHT CARRYING BUNDLE) BROKEN, THE U/D LOCK LEVER BROKEN, THE REMOTE CONTROL BUTTONS LEAK, AND THE LIGHT GUIDE CABLE FOR CONTROL BODY LEAK; 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(FLUID DAMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662382 PENTAX VIDEO LARYNGOSTROBOSCOPE (90 SERIES) EQL HOYA CORPORATION PENTAX TOKYO OFFICE VLS-1190STK 04961333226238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown