BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22952748 · Received September 3, 2025

    Report

    Report Number
    3005875675-2025-00041
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    May 8, 2023
    Report Date
    September 3, 2025
    Manufacturer
    GYNESONICS
    Product Code
    KNF
    UDI-DI
    10817929020333
    PMA / PMN Number
    K222304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF DEVICE MALFUNCTION DURING THE PROCEDURE AN 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 (B)(6) 2025 AND IS BEING REPORTED RETROACTIVELY OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS INITIALLY REPORTED TO GYNESONICS THAT A PATIENT WHO WAS TREATED WITH THE SONATA SYSTEM WAS ADMITTED TO THE ICU OF A SEPARATE HOSPITAL FOR PRESUMPTIVE SEPSIS. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023, DOCTOR INFORMED GYNESONICS MEDICAL DIRECTOR THAT THE PATIENT HAD A "LARGE" FIBROID AND IT WAS INITIALLY RESECTED THEN ABLATED. 1-2 WEEKS LATER THE PATIENT WAS SEEN IN AN ER FOR PAIN AND SHE WAS SENT HOME ON MEDS (ANTIBIOTICS). A FEW DAYS LATER SHE PRESENTED AGAIN AT AN OUTSIDE HOSPITAL, SHE WAS ADMITTED FOR AN INFECTION, AND SHE UNDERWENT A HYSTERECTOMY PROCEDURE. AS OF THE DATE THIS INFORMATION WAS REPORTED, PATIENT STILL IN THE ICU. NO FURTHER INFORMATION WAS REPORTED REGARDING THE STATUS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733907 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