BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 15750480 · Received November 8, 2022

    Report

    Report Number
    9610877-2022-59658
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    October 14, 2022
    Report Date
    November 8, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASS1 PRODUCT SO THAT 510K# IS BLANK. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD MODULE DISTORTED IMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE. IN ADDITION, WE CONFIRMED THAT THE U/D KNOB BROKEN, THE LIGHT GUIDE FIBER BUNDLE (LCB) BROKEN, THE U/D LOCK LEVER BROKEN, THE INSERTION FLEXIBLE TUBE (IFT) BUCKLED, THE LIGHT GUIDE CABLE BUCKLED, THE LIGHT GUIDE CABLE FOR CONTROL BODY BUCKLED, THE LG ROOT BRACE RUBBER CRACKED, THE ELECTRICAL CONNECTOR CORRODED, THE INSERTION FLEXIBLE TUBE (IFT) CRUSHED, THE LIGHT GUIDE CABLE CRUSHED, THE REMOTE CONTROL BUTTONS LEAK, THE ELECTRICAL CONNECTOR LEAK, THE REMOTE CONTROL BUTTONS CUT, AND THE U/D KNOB LOOSE; HOWEVER, THEY 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2376414 PENTAX VIDEO LARYNGOSTROBOSCOPE (90 SERIES) EQL HOYA CORPORATION PENTAX TOKYO OFFICE VLS-1190STK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown