BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CV41 PROBE

    MDR report key: 13689402 · Received March 8, 2022

    Report

    Report Number
    1528028-2022-00003
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    June 3, 2020
    Report Date
    March 7, 2022
    Manufacturer
    FUJIFILM HEALTHCARE CORPORATION
    Product Code
    IYN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON JUNE 18, 2020, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI MEDICAL SYSTEMS AMERICA, INC.) RECEIVED A COMPLAINT REGARDING THE CV41 ULTRASOUND PROBE. THE SITE REPORTED A FAILED BIOPSY PROCEDURE. THE C41V IS A CONVEX ARRAY ELECTRONIC SCANNING PROBE, DESIGNED TO USE WITH A HITACHI ULTRASOUND SCANNER. DURING THE REPORTED EVENT, A NOBLUS ULTRASOUND SYSTEM WAS BEING USED WITH THE PROBE, ALONG WITH A 18G - 20CM NEEDLE WITH A RE-USABLE NEEDLE GUIDE. THE PHYSICIAN'S ASSISTANT CONDUCTED THE PROSTATE BIOPSY PROCEDURE AND THEN CONTACTED HITACHI TO REPORT A FAILED PROCEDURE; NO PROSTATE TISSUE WAS COLLECTED DURING THE PROCEDURE. THE PROCEDURE WAS CONDUCTED ON (B)(6) 2020. THE PATIENT IS DOING WELL. A SECOND BIOPSY PROCEDURE WAS SCHEDULED FOR THE PATIENT. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH 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
    1621621 CV41 PROBE CV41 PROBE IYN FUJIFILM HEALTHCARE CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other