BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22909751 · Received August 27, 2025

    Report

    Report Number
    3005875675-2025-00008
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    July 30, 2021
    Report Date
    August 27, 2025
    Manufacturer
    GYNESONICS
    Product Code
    KNF
    UDI-DI
    10817929020326
    PMA / PMN Number
    K211535
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF DEVICE MALFUNCTION DURING THE PROCEDURE AND THE SYSTEM FUNCTIONED AS EXPECTED. SUBMISSION OF THIS REPORT IS ASSOCIATED WITH THE RECENT ACQUISITION OF GYNESONICS BY HOLOGIC, INC. DURING THE INTEGRATION INTO HOLOGIC'S ADVERSE EVENT REPORTING SYSTEM AND PROCEDURES, A REVIEW OF HISTORICAL ADVERSE EVENTS WAS PERFORMED. AS A RESULT, THIS EVENT WAS IDENTIFIED AS BEING REPORTABLE ON AUG 12, 2025, AND IS BEING REPORTED RETROACTIVELY OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    A PATIENT THAT WAS TREATED ON THIS DAY WAS RE-ADMITTED WITH COMPLAINT OF URINARY COMPLICATION. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION FROM GYNESONICS CLINICAL SPECIALIST, INDICATING THAT PATIENT EXPERIENCED URINARY RETENTION ISSUES. SHE ENDED UP WITH A "LEG BAG" FOR 7 DAYS POST PROCEDURE. PATIENT ETHNICITY WAS AFRICAN AMERICAN WOMEN WHO HAD A PREVIOUS ACESSA PROCEDURE AND A LOWER SEGMENT FIBROID

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2742615 SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM KNF GYNESONICS SONATA2-110 10817929020326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H ACESSA PROCEDURE - DATE UNKNOWN.