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); Unspecified Reproductive System or Breast Problem (4513); Pelvic Pain (4865)
Date of Event	10/05/2023
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) 2023 hysteroscopic rfa of 3 fibroids, no em polyp noted.Indentation of lt emc due to figo grade 3 im myoma.Mirena placed.Pt reported severe cramping pod#1 with resolution the following day.On (b)(6) 2023 presented to er with sever pelvic pain, low grade temp (100.5), abnormal foul smelling vaginal dc.Dx with uti and tx with keflex, did not take metrogel for bv.-ct demonstrated fibroid within emc on (b)(6) 2023 afvss.Sve 4cm dilated by fibroids.Unsuccessful attempts of removal in office.On (b)(6) 2023 taken to or and fibroid removed vaginally via morcellation.Inverted malpositioned iud removed.Shaggy em lining in right lateral cavity (suspected site of prolapse?).

• 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
• 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: 22929552
• Report Number: 3005875675-2025-00027
• Device Sequence Number: 9079718
• Product Code: KNF
• UDI-Device Identifier: 10817929020326
• UDI-Public: (01)10817929020326
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• 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: 12/19/2023
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2022
• 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: HYSTEROSCOPE; MIRENA PLACED; MORCELATION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female