BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222494 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10223
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    January 1, 2021
    Report Date
    July 24, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    UDI-DI
    04961333239597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG36-J10UR-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K200090. EVALUATION SUMMARY: THE CUSTOMER CONCERNS THE UNEVEN O-RING GAP ON THE CONNECTOR; HOWEVER, IT IS NOT AFFECT FUNCTION AND SAFETY. IN FACT, THERE IS NO SUCH COMPLAINTS WE RECEIVED. IT IS MANUFACTURED AS THE ORIGINAL DESIGN. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    FOR EVALUATION(EG36-J10UR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119487 PENTAX DIGITAL RADIAL ULTRASOUND SCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG36-J10UR 04961333239597

    Patients

    Seq Age Sex Outcome Treatment
    1