BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22952749 · Received September 3, 2025

    Report

    Report Number
    3005875675-2025-00042
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    May 9, 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
    UK
    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. BASED ON THE INFORMATION PROVIDED, THIS DOES NOT SEEM TO BE AN ADVERSE EVENT CASE, RATHER A SITUATION WHERE A PATIENT MIGHT NOW BE DISSATISFIED WITH THE RESULTS PLUS THE SYMPTOMS; THESE WERE HER PRE-PROCEDURE SYMPTOMS TOO AND IS STILL EXPERIENCING PAIN FROM HER FIBROID. DOCTOR ATTEMPTED TO CONTACT HER AND FOLLOW UP AGAIN, BUT IT IS HARD TO HELP AS SHE IS NOT IN THE CORRECT AREA OF THE COUNTRY. GYNESONICS MEDICAL DIRECTOR CONCURS WITH THE SURGEON'S OPINION, HE HAD CERTAINLY SEEN AND MANAGED MANY PATIENTS WITH CHRONIC PELVIC PAIN (WHICH REQUIRES A DURATION OF SIX MONTHS TO BE CONSIDERED CHRONIC PELVIC PAIN) AND IT'S A PROBLEM WITH GENERALLY VERY INADEQUATE TREATMENT. 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 (B)(6) 2023, IT WAS INITIALLY REPORTED THOUGH IG SOCIAL MEDIA THAT A PATIENT WHO LIVES IN UK, WAS TREATED WITH THE SONATA SYSTEM IN (B)(6) 2022 AT (B)(6), PATIENT ALLEGED THAT 5 MONTHS LATER SHE STILL HAS PERSISTENT PAIN IN THE AREA, INCREASED BY PHYSICAL ACTIVITY, REMAINING SEATED LONG TIME AND SEXUAL INTERCOURSE. ACCORDING TO THE PATIENT, NOTHING WRONG HAS BEEN OBSERVED IN THE ULTRASOUND SCANS. SHE ALLEGED THAT SHE IS NOT GETTING ENOUGH SUPPORT FROM NHS AND THIS IS IMPACTING HER LIFE SIGNIFICANTLY. SHE IS ASKING FOR HELP. ON (B)(6) 2023, GYNESONICS MARKETING SALES MANAGER SPOKE WITH THE SURGEON WHO PERFORMED THIS CASE. THE SURGEON REMEMBERS THE PATIENT, HE MENTIONED THAT PATIENT ARRIVED IN THE OPD LISTED FOR A SONATA PROCEDURE AND SHE WASN'T AWARE ON WHAT SHE WAS GOING TO HAVE SO PATIENT WAS COUNSELLED, THEN SHE WAS SENT AWAY AND THEN RETURNED FOR THE PROCEDURE ANOTHER DAY. PATIENT SPOKE VERY POOR ENGLISH AND HER HUSBAND INTERPRETED FOR HER. THE PROCEDURE WENT EXTREMELY WELL, SHE TOLERATED IT WELL UNDER LOCAL ANESTHETIC. SHE THEN MOVED DOWN SOUTH, AND THE SURGEON HASN'T HEARD FROM HER AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733908 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 Other