BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENTAX ENDOSCOPY ULTRASOUND

    MDR report key: 19722207 · Received July 10, 2024

    Report

    Report Number
    MW5157204
    Event Type
    Other
    Date Received
    July 10, 2024
    Date of Event
    June 4, 2024
    Report Date
    July 8, 2024
    Manufacturer
    HOYA CORPORATION PENTAX LIFECARE DIVISION
    Product Code
    ODG
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER THE ESOPHAGOGASTRODUODENOSCOPY WITH ENDOSCOPIC ULTRASOUND, MULTIPLE RED MARKINGS IN THE GASTRIC TISSUE WAS NOTICED. NO BLEEDING NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386359 PENTAX ENDOSCOPY ULTRASOUND ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY ODG HOYA CORPORATION PENTAX LIFECARE DIVISION EG38-J10UT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose