BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16841481 · Received April 30, 2023

    Report

    Report Number
    9610877-2023-53930
    Event Type
    Malfunction
    Date Received
    April 30, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 1, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EB-1575K IS AVAILABLE IN THE USA WITH A 510K NUMBER K131028. 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. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702168 PENTAX VIDEO CYSTOSCOPE 2.0C 5.5TP 400L FAJ HOYA CORPORATION PENTAX TOKYO OFFICE ECY-1575K

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown