BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 19727691 · Received July 12, 2024

    Report

    Report Number
    9610877-2024-55334
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    July 5, 2024
    Report Date
    July 12, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 DRIVE PCB FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE CCD DRIVE PCB. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE REMOTE CONTROL BUTTONS PERFORATED, THE CCD DRIVE PCB CORRODED, THE LIGHT GUIDE CABLE COLLAPSE, 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(FLUID DAMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341344 PENTAX VIDEO LARYNGOSTROBOSCOPE (SLIM) EQL HOYA CORPORATION PENTAX TOKYO OFFICE VLS-1070STK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown