BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22964011 · Received September 4, 2025

    Report

    Report Number
    3005875675-2025-00059
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    November 4, 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
    NC, 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

    ON NOVEMBER 07, 2024 IT WAS INITIALLY REPORTED TO GYNESONICS THAT A PATENT WHO WAS TREATED WITH THE SONATA SYSTEM FOR 1 FIBROID AND 1 AREA OF ADENO/FIBROID ON MONDAY (B)(6) 2024 AND PATIENT CALLED PHYSICIAN ON THURSDAY (B)(6) 2024 COMPLAINING OF SEVERE PAIN AND DIFFICULTY WALKING AND GETTING UP. DOCTOR SPOKE TO GYNESONICS MEDICAL DEVICE DIRECTOR AND DOCTOR WAS GOING TO BRING THE PATIENT IN TO DO AN ULTRASOUND. ADDENDUM: UPON FOLLOWING UP THE NEXT DAY WITH DOCTOR, SHE INDICATED THAT THE PATIENT WENT TO AN OUTSIDE HOSPITAL AND SHE DOES NOT YET KNOW WHAT TRANSPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017433 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