MAUDE Adverse Event Report: GYNESONICS SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM; ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM

Model Number	SONATA2-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Abnormal Vaginal Discharge (2123)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated on (b)(6) 2024 for aub a/w multiple fibroids (14-week uterus per dr.Gonzalez).The patient was treated with elagolix and remains on it.The procedure took 84 minutes and 6 fibroids were treated, the largest being a 6-cm transmural fibroid (the others were all small 1-1.5 cm intramural [and one submucous)] fibroids).The 6-cm fibroid received three ablations.The pt did well in the interim with reduced aub.One week ago, she noticed increased leukorrhea with odor.Today, she had a temp of 100.1º at home and passed a clot with some spotting.She was sent to the emergency room and admitted, placed on iv antibiotics and motrin.The patient is still being evaluated, but the tmax was 100.7% and it is not known if she has any lab abnormalities.Imaging has not yet been done.
Additional Manufacturer Narrative
There was no report of device malfunction during the procedure and the system functioned as expected.Per gynesonics md this appears consistent with postablation inflammation symptoms.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 (b)(6), 2025 and is being reported retroactively out of an abundance of caution.

• Brand Name: SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM
• Common Device Name: ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM
• Manufacturer (Section D): GYNESONICS; 200 cardinal way #250; redwood
• Manufacturer (Section G): GYNESONICS; 200 cardinal way; #250; redwood city CA 94063
• Manufacturer Contact: timothy rossi ; 200 cardinal way; #250; redwood, CA 94063 ; 6502416115
• MDR Report Key: 22964015
• Report Number: 3005875675-2025-00047
• Device Sequence Number: 13049175
• Product Code: KNF
• UDI-Device Identifier: 10817929020326
• UDI-Public: (01)10817929020326(11)220107
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SONATA2-110
• Device Catalogue Number: SONATA2-110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THE PATIENT WAS TREATED WITH ELAGOLIX AND REMAINS.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female