BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 20720259 · Received November 19, 2024

    Report

    Report Number
    9610877-2024-58427
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 30, 2024
    Report Date
    November 19, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    PMA / PMN Number
    K182004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4 UDI: "NOT DISTRIBUTED IN USA", BECAUSE PRODUCTS ARE NOT DISTRIBUTED IN USA PRODUCTS, BUT SIMILAR DEVICE PRODUCT ARE LISTED IN USA. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OBJECTIVE PRISM CLOUDY (NOT CLEAR VIEW). BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE MOISTURE CONDENSATION IN THE OBJECTIVE PRISM. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE ROOT BRACE RUBBER (INSERTION FLEXIBLE TUBE) CUT, THE OPERATION CHANNEL (PRIMARY) DIRTY, THE BALLOON FEEDER RETURN TUBE DIRTY, THE AFT SUCTION TUBE DIRTY, THE SUCTION CHANNEL DIRTY, THE LG WATER SUPPLY TUBES DIRTY, THE LG AIR SUPPLY TUBES DIRTY, AND THE INSERTION FLEXIBLE TUBE ATTACHING NUT LOOSE; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. THIS DEFECT OCCURRED NOT DURING PROCEDURE. 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 (CLOUDY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75043 PENTAX LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG-3870UTK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown