BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22929552 · Received August 29, 2025

    Report

    Report Number
    3005875675-2025-00027
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    October 5, 2023
    Report Date
    August 29, 2025
    Manufacturer
    GYNESONICS
    Product Code
    KNF
    UDI-DI
    10817929020326
    PMA / PMN Number
    K222304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 (B)(6) 2023 HYSTEROSCOPIC RFA OF 3 FIBROIDS, NO EM POLYP NOTED. INDENTATION OF LT EMC DUE TO FIGO GRADE 3 IM MYOMA. MIRENA PLACED. PT REPORTED SEVERE CRAMPING POD#1 WITH RESOLUTION THE FOLLOWING DAY. ON (B)(6) 2023 PRESENTED TO ER WITH SEVER PELVIC PAIN, LOW GRADE TEMP (100.5), ABNORMAL FOUL SMELLING VAGINAL DC. DX WITH UTI AND TX WITH KEFLEX, DID NOT TAKE METROGEL FOR BV. -CT DEMONSTRATED FIBROID WITHIN EMC ON (B)(6) 2023 AFVSS. SVE 4CM DILATED BY FIBROIDS. UNSUCCESSFUL ATTEMPTS OF REMOVAL IN OFFICE. ON (B)(6) 2023 TAKEN TO OR AND FIBROID REMOVED VAGINALLY VIA MORCELLATION . INVERTED MALPOSITIONED IUD REMOVED. SHAGGY EM LINING IN RIGHT LATERAL CAVITY (SUSPECTED SITE OF PROLAPSE?).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131103 SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM KNF GYNESONICS SONATA2-110 10817929020326

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention HYSTEROSCOPE| MIRENA PLACED| MORCELATION