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 Code	Menstrual Irregularities (1959)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
A patient treated on what we believe was on (b)(6) 2023.Fibroid size: 6cm.Fibroid type: 2-5.Ablations- 2 ablations.Per the treating physician: this patient was also given an iud after the case.Patient did well for 4 months and then their bleeding became uncontrollable according to physician.A follow up mri and ultrasound measured an 8 cm mass (she wasn't 100% sure on size but thought it had grown), which was partially prolapsing.She did not report any pain, just increased bleeding.The patient had a hysterectomy with part of the fibroid attached to a small stalk.

• 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 city CA 94023
• 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: 22963995
• Report Number: 3005875675-2025-00051
• Device Sequence Number: 13075890
• Product Code: KNF
• UDI-Device Identifier: 10817929020326
• UDI-Public: (01)10817929020326(11)191029
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K222304
• 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: 06/07/2024
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2019
• 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: IUD PLACED IMMEDIATELY AFTER THE CASE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female