BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 18214146 · Received November 28, 2023

    Report

    Report Number
    9610877-2023-61198
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    November 13, 2023
    Report Date
    November 28, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL VNL11-J10 IS AVAILABLE IN THE USA WITH A 510K NUMBER K172156. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD MODULE WITH DRIVE PCB AS DEFECTIVE. 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 CONTROL BODY CORRODED, THE REMOTE CONTROL BUTTONS CUT, THE ELECTRICAL PIN CONNECTOR DIRTY, THE SEGMENT WORN OUT, THE INSERTION FLEXIBLE TUBE DENTED, AND THE CCD MODULE WITH DRIVE PCB DISTORTED IMAGE; 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764801 PENTAX VIDEO LARYNGOSTROBOSCOPE (90 SERIES) EQL HOYA CORPORATION PENTAX TOKYO OFFICE VLS-1190STK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown