BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 15593837 · Received October 13, 2022

    Report

    Report Number
    9610877-2022-58788
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 21, 2022
    Report Date
    October 13, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 BLACKOUT. 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 INSERTION FLEXIBLE TUBE (IFT) FLUID DAMAGE, THE LIGHT GUIDE CABLE FLUID DAMAGE, THE LG CABLE CONNECTOR FLUID DAMAGE, THE LIGHT GUIDE FIBER BUNDLE (LCB) BROKEN, THE REMOTE CONTROL BUTTONS CRACKED, THE CCD DRIVER PCB CORRODED, THE ELECTRICAL CONNECTOR CORRODED, THE LG CABLE CONNECTOR CORRODED, AND THE REMOTE CONTROL BUTTONS MISCONFIGURED; 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(BLACKOUT ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2581956 PENTAX VIDEO LARYNGOSTROBOSCOPE (90 SERIES) EQL HOYA CORPORATION PENTAX TOKYO OFFICE VLS-1190STK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown