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	Dyspnea (1816); Unspecified Infection (1930)
Date of Event	05/20/2024
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
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.

• 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: 22963990
• Report Number: 3005875675-2025-00048
• Device Sequence Number: 9257198
• Product Code: KNF
• UDI-Device Identifier: 10817929020326
• UDI-Public: (01)10817929020326
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: 05/20/2024
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female