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	Menstrual Irregularities (1959); Pelvic Pain (4865)
Date of Event	09/16/2024
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
The patient is a g0 with morbid obesity who had had multiple encounters for fibroid symptoms prior to being treated with sonata two weeks ago for a 3-cm type 2 fibroid.The physician describes her as a "high maintenance" patient with "low pain tolerance." she recently complained about a "light period" post-treatment along with pain, and was seen the emergency room 3-4 times since undergoing tfa, and was admitted on 9/16 for evaluation and is scheduled for hysterectomy on 9/20, which is why she remains in house.There is no evidence of infection-no fevers, no elevated wbc.She was placed on iv ampicillin/sulbactam empirically and was also treated with toradol, "vaginal valium" and tylenol.Bleeding was also managed with tranexamic acid.Her hb on admission was 12 mg/dl and dropped after hydration to 10.4.Mg/dl.Per the treating physician, the patient simply wants a hysterectomy and is not being discharged until she either undergoes hysterectomy at the end of the week or else chooses to be discharged.

• 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 94063
• 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: 22964014
• Report Number: 3005875675-2025-00056
• Device Sequence Number: 15740930
• Product Code: KNF
• UDI-Device Identifier: 10817929020326
• UDI-Public: (01)10817929020326(11)230919
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K240503
• 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: 09/16/2024
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female