BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22964008 · Received September 4, 2025

    Report

    Report Number
    3005875675-2025-00058
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    October 8, 2024
    Report Date
    September 4, 2025
    Manufacturer
    GYNESONICS
    Product Code
    KNF
    UDI-DI
    10817929020326
    PMA / PMN Number
    K240503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    5.5CM SUBMUCOSAL FIBROID TREATED. DID "GREAT "FOR 4 DAYS. THEN GOT CONSTIPATED AND WAS IN PAIN. NOW WITH WORSENING CRAMPING AND A 4X4X6CM ENDOMETRIAL STRIPE ON CT- WAS IN THE ER DUE TO THE PAIN. NECROTIC FIBROID TISSUE IS THE PHYSICIAN'S SUSPICION AND SHE IS PLANNING TO TAKE HER FOR A D&C IN THE AM. BOWEL SOUNDS NORMAL. WBC 12.8. NO FEVER; DOES NOT LOOK SICK. (B)(6) 2024: "PT DID WELL. WBC 8.2 PRIOR TO SURG. FIBROIDS EXTRUDING INTO ENDOMETRIAL CAVITY SHAVED DOWN AND MOSTLY REMOVED WITH MYOSURE XL UNDER US GUIDANCE. SHE DID NOT REQUIRE ANY EXTRA PAIN MEDS AFTER SURGERY SO FAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017430 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 Hospitalization| R