BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBLUS

    MDR report key: 13688907 · Received March 8, 2022

    Report

    Report Number
    1528028-2022-00008
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    February 2, 2021
    Report Date
    March 7, 2022
    Manufacturer
    FUJIFILM HEALTHCARE CORPORATION
    Product Code
    IYN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON FEBRUARY 2, 2021, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI MEDICAL SYSTEMS AMERICA, INC) RECEIVED A COMPLAINT REGARDING NOBLUS ULTRASOUND. THE SITE REPORTED THAT THE SYSTEM BOOTED UP AND WAS ABLE TO SCAN BUT THEN THE IMAGE FROZE. THE SITE WAS NOT ABLE TO UNFREEZE THE IMAGE. THE PATIENT WAS UNDER ANESTHESIA DURING THE TROUBLESHOOTING PROCESS. THE STAFF WAS UNABLE TO UNFREEZE THE IMAGE SO THE PROSTATE BIOPSY PROCEDURE WAS ABORTED/CANCELLED. THE PROCEDURE WAS RESCHEDULED FOR ANOTHER DAY. THERE WAS NO INJURY/HARM OR DEATH REPORTED WITH THIS EVENT. DURING A RETROSPECTIVE REVIEW, IT WAS DISCOVERED THAT THE MANUFACTURER HAD ASSESSED THIS EVENT AS AE LEADING TO SERIOUS INJURY; THEREFORE AN IMPORTER'S MDR IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654510 NOBLUS NOBLUS IYN FUJIFILM HEALTHCARE CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other