BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBLUS

    MDR report key: 13686566 · Received March 8, 2022

    Report

    Report Number
    1528028-2022-00014
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    September 20, 2021
    Report Date
    March 7, 2022
    Manufacturer
    FUJIFILM HEALTHCARE CORPORATION
    Product Code
    IYN
    UDI-DI
    04580292771704
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI HEALTHCARE AMERICAS CORPORATION) RECEIVED A COMPLAINT REGARDING NOBLUS ULTRASOUND. THE SITE REPORTED THAT A PATIENT WAS UNDER ANESTHESIA AND UNDERGOING A PROSTATE CRYO PROCEDURE WITH A BI-PLACE C41L47RP PROBE. SITE TECHNICIAN TURNED ON THE NOBLUS SYSTEM AND ATTACHED THE PROBE. THE SYSTEM WOULD NOT BOOT UP READY AND REPORTED AN ERROR ASKING TO "PLEASE WAIT UNTIL THE ERROR LOG IS COMPLETE." A PROMPT WOULD POP UP WITH THE OPTION TO HIT "OK", AND WHEN HE DID, THE SYSTEM WOULD SHUT DOWN. TECH ATTEMPTED TO REBOOT SEVERAL TIMES, BOTH WITH AND WITHOUT A PROBE ATTACHED, AND EVEN TRIED TO REPLACE THE BATTERY. ERROR PERSISTED. THE PROCEDURE WAS RESCHEDULED. THERE WERE NO SIDE EFFECTS FROM THE ANESTHESIA AND THE PATIENT WAS CLEARED TO GO HOME. 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
    1364018 NOBLUS NOBLUS IYN FUJIFILM HEALTHCARE CORPORATION N/A N/A 04580292771704

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other