BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22910116 · Received August 27, 2025

    Report

    Report Number
    3005875675-2025-00021
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    March 25, 2023
    Report Date
    August 27, 2025
    Manufacturer
    GYNESONICS
    Product Code
    KNF
    UDI-DI
    10817929020326
    PMA / PMN Number
    K222304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. CLINICAL IMPRESSION OF BOTH TREATING PHYSICIAN AND THE GYNESONICS MEDICAL DIRECTOR: HEMATOMETRIUM, NO EVIDENCE OF INFECTION. 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

    50 YO WITH MULTIPLE LARGE FIBROIDS (5-6 CM RANGE), MANAGED WITH LEUPROLIDE ACETATE X 6 MONTHS THEN DECIDED TO BE TREATED WITH SONATA TO BRIDGE HER TO MENOPAUSE. TX DATE WAS (B)(6) 2023. FOUR FIBROIDS (5, 4, 4.5, 5 CM) TREATED OVER 77 MINUTES VIA 7 ABLATIONS. D/C'D HOME AND DID WELL UNTIL (B)(6) 2023-FELT FEVERISH AND CAME TO EW: TREATED WITH PO ABX FOR PRESUMPTIVE ENDOMETRITIS BUT RETURNED ON (B)(6) WITH FEVERS. BC + FOR SKIN CONTAMINANT ONLY. ADMITTED AND PLACED ON IV ABX. IMAGING (CT) ON (B)(6): ENDOMETRIUM WITH FLUID AND GAS. CANNOT R/O INFECTION. REPEAT CT: INCREASED FLUID (7X7X8 CM)IN CAVITY AND PHYSICIANS NOTED NO DRAINAGE PER CERVIX. OFFERED HYSTERECTOMY BUT PATIENT DECLINED. SUCTION CURETTAGE PERFORMED ON (B)(6) TO EVACUATE HEMATOMETRA AND QUICKLY IMPROVED AND SIGNED OUT AMA ONE DAY LATER. CULTURES WERE ALL NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834414 SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM KNF GYNESONICS SONATA2-110 10817929020326

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention| H