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	Urinary Retention (2119); Constipation (3274); Pelvic Pain (4865)
Date of Event	03/04/2024
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 40 yo type ii diabetic maintained on metformin with a history of aub-l secondary to a 6.5-cm type 2 fibroid.Her hbaic most recently was 6.7% on (b)(6).She was treated with tfa on (b)(6) 2024; the case was reportedly unremarkable, performed under mac, and five ablations were carried out on the one fibroid.From 9:00 [?] 4:00, the patient remained in the recovery room due to significant postop pain but was d/c'd home in stable condition.On (b)(6) 2024 (pod#3), the patient was evaluated in the ew of an outside hospital due to increasing pain, obstipation, infrequent urination.She was afebrile, and denied nausea, emesis, fever or chills.She denied rectal flatus or a bowel movement.There was no urinary frequency or urgency.During the course of her evaluation, she was medicated with toradol x 2, tylenol, dilaudid, fentanyl, oxycodone and gabapentin.W/u: wbc 5.2, pex: some lower abdominal discomfort ct of the abdomen and pelvis: essentially negative (the treated fibroid was noted along with some free fluid in the cul-de-sac).There was no free air or other intraperitoneal abnormalities.The patient started to improve and was sent home.

• 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 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: 22964023
• Report Number: 3005875675-2025-00045
• Device Sequence Number: 21119979
• Product Code: KNF
• UDI-Device Identifier: 10817929020326
• UDI-Public: (01)10817929020326(11)220309
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Literature,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: 03/04/2024
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female