BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HITACHI

    MDR report key: 20384141 · Received October 7, 2024

    Report

    Report Number
    20384141
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    August 6, 2024
    Report Date
    August 14, 2024
    Manufacturer
    HOYA CORPORATION PENTAX DIVISION
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MRI PROSTATE BIOPSY PROBE WASN¿T WORKING PROPERLY. THE REP SHOWED THAT CRYSTALS ON SCREEN REQUIRED EXTRA PRESSURE TO PRODUCE IMAGE. A REPLACEMENT PROBE WAS PROCESSED AND OBTAINED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2546348 HITACHI SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN HOYA CORPORATION PENTAX DIVISION C41V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose