BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12678043 · Received October 21, 2021

    Report

    Report Number
    9610877-2021-01227
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    October 11, 2021
    Report Date
    February 9, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE DEVICE HAS BEEN REPAIRED AND THE US PROBE REPLACED.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG38-J10UT-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K200090. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    THE US PROBE IS LEAKY. THIS EVENT OCCURRED AT THE TIME OF DURING INSPENCTION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567955 PENTAX DIGITAL LINEAR ULTRASOUND SCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG38-J10UT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown