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); Unspecified Infection (1930); Pelvic Pain (4865)
Date of Event	06/15/2024
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 (b)(6), 2025 and is being reported retroactively out of an abundance of caution.
Event or Problem Description
Treating physician reported a patient with a fever of 102.4 and myalgias chills and came to er.Blood cultures x 1 and urine culture (10k) positive for gbs suspect she has vaginal colonization, and that seeded either via hysteroscopy or thru sonata.Ctscan normal on admission-but i may repeat it.She's now been febrile for 48 hours.Still with more uterine pain than i'd like- but repeat blood cultures from today are pending.Based on that, id will make recommendations regarding length of antibiotics." the patient was treated on 6/14/24 and was admitted on (b)(6) 2024 due to the above chief complaints.Evaluation is ongoing at this time.Based on the fever and uterine pain, this is consistent with endometritis, likely due to group b streptococcus ascending infection.On (b)(6) 2024 gynesonics md was notified by treating physician, the patient was discharged on friday, (b)(6), 2024 with a diagnosis of group b streptococcal bacteremia.She also felt that given the patient's abdominal pain, this was consistent with endometritis although she was not sure if it could have been routine postop pain as well.The patient's second set of blood cultures were negative and she was switched to oral antibiotics and will be seen in follow-up on (b)(6) 2024.

• 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: 22963997
• Report Number: 3005875675-2025-00052
• Device Sequence Number: 13075891
• Product Code: KNF
• UDI-Device Identifier: 10817929020326
• UDI-Public: (01)10817929020326(11)210809
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 06/18/2024
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female