BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12424044 · Received September 3, 2021

    Report

    Report Number
    9610877-2021-00797
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    January 1, 2021
    Report Date
    September 3, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PENTAX MODEL EC38-I10F2 IS NOT DISTRIBUTED IN THE USA, THEREFORE 510K IS NOT APPLICABLE. WE DO HAVE SIMILAR MODEL EG36-J10UR-US AVAILABLE IN THE UNITED STATES WITH A 510K NUMBER K200090. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN THE (B)(6) STATING, "PUK: LEAKING FROM IFT ROOT BRACE." INVOLVING PENTAX ULTRASOUND VIDEOSCOPE MODEL EG36-J10UR/SERIAL (B)(4). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT/IMPORTANT MEDICAL EVENT. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT. THE DEVICE WAS RETURNED TO PENTAX MEDICAL (B)(4) SERVICE WORKSHOP WHERE THE FOLLOWING WAS CONFIRMED: IFT LOOSENED, LEAKY. THE IFT WILL BE FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317063 PENTAX DIGITAL RADIAL ULTRASOUND SCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG36-J10UR

    Patients

    Seq Age Sex Outcome Treatment
    1