BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22963990 · Received September 4, 2025

    Report

    Report Number
    3005875675-2025-00048
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    May 20, 2024
    Report Date
    September 4, 2025
    Manufacturer
    GYNESONICS
    Product Code
    KNF
    UDI-DI
    10817929020326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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) 2024, IT WAS REPORTED THAT A PATIENT WAS TREATED WITH THE SONATA SYSTEM ENDED UP NEEDING TO GO TO THE HOSPITAL AND IS BEING TREATED CURRENTLY FOR SUSPECTED ENDOMETRITIS. THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL, ON (B)(6) 2024, WITH ORAL ANTIBIOTICS. THE PRESUMED DIAGNOSIS WAS ENDOMETRITIS, HOWEVER, SHE NEVER HAD A FEVER. ON (B)(6) 2024, GYNESONICS MEDICAL DIRECTOR (B)(4) RECEIVED ADDITIONAL INFORMATION FROM TREATING PHYSICIAN THE PATIENT WAS A 48-YEAR-OLD WOMAN WHO UNDERWENT TFA ON (B)(6) 2024. SHE HAD A HISTORY OF AMENORRHEA X MONTHS (MENOPAUSAL) BUT HAD A "SUBSTANTIAL" ENDOMETRIAL THICKNESS ON U/S; EMBX NEGATIVE FOR MALIGNANCY/HYPERPLASIA. HISTORY OF SEPTIC ABOUT 10 YEARS AGO. FIVE FIBROIDS TREATED-LARGEST AROUND 5 CM. POD # 6: CALLED WITH COMPLAINTS OF BLEEDING, FATIGUE, DYSPNEA. SEEN BY TREATING PHYSICIAN, BENIGN EXAM, CBC NOTEWORTHY FOR HB 12.1 G/DL (MINIMAL DECREASE FROM 12.4 PREOP) BUT WBC 13. AFEBRILE. POD #11: PRESENTED WITH DYSPNEA AND OTHER COMPLAINTS. PE W/U WAS NEGATIVE. PELVIC CT: FLUID WITH AIR IN PELVIS. PATIENT TACHYCARDIC TO 130'S. WBC 21 WITHOUT A LEFT SHIFT. PATIENT ADMITTED WITH A PRESUMPTIVE DIAGNOSIS OF ENDOMETRITIS. ADMITTED 4-5 DAYS (D/C'D HOME ON (B)(6) 2024). NEVER SPIKED A FEVER. MAINTAINED ON BROAD-SPECTRUM PARENTERAL ABX. BLOOD CULTURES NEGATIVE, CXR NEGATIVE. URINE CULTURE INITIALLY POSITIVE FOR A CONTAMINANT; REPEAT WAS NEGATIVE. U/S: 3 CM ENDOMETRIAL LINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851813 SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM KNF GYNESONICS SONATA2-110 10817929020326

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Hospitalization