BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 17313746 · Received July 13, 2023

    Report

    Report Number
    9610877-2023-56507
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 29, 2023
    Report Date
    July 13, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 EB15-J10 IS AVAILABLE IN THE USA WITH A 510K NUMBER K200678. 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 INSERTION FLEXIBLE TUBE BUCKLED; HOWEVER, THIS DEFECT IS 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 NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248113 PENTAX VIDEO BRONCHOSCOPE EOQ HOYA CORPORATION PENTAX TOKYO OFFICE EB11-J10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown