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); Urinary Tract Infection (2120); Pelvic Pain (4865)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
44 yo women treated on (b)(6) (around a month ago) for a symptomatic 6-cm posterior fibroid.Tfa and hysteroscopic myomectomy was performed and the patient received abx prophylaxis.Was seen initially in the emergency ward two weeks postop for pain, self-reported fever (not documented) and a mildly elevated wbc with a left shift starting.Given ceftriaxone in the ew and went home on a 14-day course of doxy + flagyl.Imaging showed no acute process.Last ew visit was (b)(6) for back pain, bloating.Wbc was 14.4 with a left shift.The examining clinician felt her pain complaints were out of proportion to her clinical exam.A second u/s was also unremarkable (no free air, no collection) and a stable small lymph node.Review of the procedure video was unremarkable-no evidence of extrauterine ablation.Several ablations were made.Last seen on (b)(6) no fevers, wbc and u/a were negative.Pex showed uterine tenderness.Still on doxycycline + metronidazole.Cultures had all been negative until her last ew visit on (b)(6); her urine culture came back positive so she had a uti at the very least.
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.

• 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 CA 94063
• Manufacturer Contact: timothy rossi ; 200 cardinal way #250; redwood, CA 94063 ; 6502416115
• MDR Report Key: 22929553
• Report Number: 3005875675-2025-00022
• Device Sequence Number: 9079719
• 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: 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): 08/29/2025

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
• 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: 10/04/2023
• Initial Report FDA Received Date: 08/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HYSTEROSCOPIC MYOMECTOMY WAS PEFORMED SAME DAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female