BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22963995 · Received September 4, 2025

    Report

    Report Number
    3005875675-2025-00051
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    November 10, 2023
    Report Date
    September 4, 2025
    Manufacturer
    GYNESONICS
    Product Code
    KNF
    UDI-DI
    10817929020326
    PMA / PMN Number
    K222304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 TREATED ON WHAT WE BELIEVE WAS ON (B)(6) 2023. FIBROID SIZE: 6CM. FIBROID TYPE: 2-5. ABLATIONS- 2 ABLATIONS. PER THE TREATING PHYSICIAN: THIS PATIENT WAS ALSO GIVEN AN IUD AFTER THE CASE. PATIENT DID WELL FOR 4 MONTHS AND THEN THEIR BLEEDING BECAME UNCONTROLLABLE ACCORDING TO PHYSICIAN. A FOLLOW UP MRI AND ULTRASOUND MEASURED AN 8 CM MASS (SHE WASN'T 100% SURE ON SIZE BUT THOUGHT IT HAD GROWN), WHICH WAS PARTIALLY PROLAPSING. SHE DID NOT REPORT ANY PAIN, JUST INCREASED BLEEDING. THE PATIENT HAD A HYSTERECTOMY WITH PART OF THE FIBROID ATTACHED TO A SMALL STALK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876469 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 IUD PLACED IMMEDIATELY AFTER THE CASE