BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 23005524 · Received September 9, 2025

    Report

    Report Number
    3005875675-2025-00069
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    March 10, 2018
    Report Date
    September 9, 2025
    Manufacturer
    GYNESONICS
    Product Code
    KNF
    UDI-DI
    10817929020333
    PMA / PMN Number
    K173703
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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) 2020, IT WAS INITIALLY REPORTED TO GYNESONICS THAT A PATIENT TREATED WITH THE SONATA SYSTEM EXPERIENCED RE-INTERVENTION FOR HMB TREATED WITH SONATA: (B)(6) 2018 FIBROID TREATED: FIGO TYPE 2-5, TRANSMURAL. SUBMITTED BY PI: TYPE II MYOMA OF THE FRONTWALL OF THE UTERUS, NOW MAINLY IN THE CAVITY OF THE UTERUS TRYING TO GO IN STATUNASCENDI, HEAVY BLEEDING AND HIGH NEED OF PAIN RELIEVE MEDICATION. AE START DATE (B)(6) 2018; END DATE (B)(6) 2018. RE-INTERVENTION SURGERY DATE: HYSTEROSCOPIC MYOMECTOMY (INCLUDES MORCELLATION) ON (B)(6) 2018, 28 DAYS POST-SONATA SAE #1-2 SUBMITTED BY PI: TYPE II MYOMA OF THE FRONTWALL OF THE UTERUS, NOW MAINLY IN THE CAVITY OF THE UTERUS TRYING TO GO IN STATU NASCENDI, HEAVY BLEEDING AND HIGH NEED OF PAIN RELIEVE MEDICATION. SAE START DATE (B)(6) 2018; END DATE (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2843627 SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM KNF GYNESONICS SONATA-240 10817929020333

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H