BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12272351 · Received August 4, 2021

    Report

    Report Number
    9610877-2021-10461
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    August 1, 2020
    Report Date
    August 4, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    UDI-DI
    04961333239498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVALUATION SUMMARY: IT WAS CAUSED DUE TO THE EXTERNAL NOISE. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THERE WAS NOISE AND INTERFERENCES AT THE US IMAGE DURING THE PROCEDURE. THE PROCEDURE COULD BE FINISHED WITHOUT PROBLEMS FOR THE PATIENT, USER OR THIRD PERSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169359 PENTAX DIGITAL LINEAR ULTRASOUND SCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG38-J10UT 04961333239498

    Patients

    Seq Age Sex Outcome Treatment
    1