BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22964001 · Received September 4, 2025

    Report

    Report Number
    3005875675-2025-00067
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    November 7, 2024
    Report Date
    September 4, 2025
    Manufacturer
    GYNESONICS
    Product Code
    KNF
    UDI-DI
    10817929020333
    PMA / PMN Number
    K240503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    ON (B)(6) 2024 IT WAS INITIALLY REPORTED TO GYNESONICS THAT A PATIENT TREATED WITH THE SONATA SYSTEM WAS HOSPITALIZED/ ADMITTED LONGER. PATIENT RECEIVED SONATA FOR A TYPE 1 FIBROID. PATIENT FELT WELL AFTER TREATMENT AND WAS DISCHARGED. AFTER 2-3 WEEKS SHE CAME IN FOR EXAMINATION WITH ABDOMINAL PAIN. SHE RECEIVED HYSTEROSCOPIC SURGERY BECAUSE THERE WERE FIBROID REMAINS IN THE CAVITY CAUSING PROBLEMS. PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876475 SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM KNF GYNESONICS SONATA2-220 10817929020333

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H