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); Pelvic Pain (4865)
Date of Event	06/20/2024
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 (b)(6) 2025 and is being reported retroactively out of an abundance of caution.
Event or Problem Description
I was contacted by treating physician about a 30 yo patient who was treated yesterday for a 9-cm type 3-5 fibroid with tfa along with laparoscopic excision of an ovarian benign cystic teratoma (dermoid).There were about 5-6 ablations placed in the fibroid and the serosa was out of harm's way throughout.After the uncomplicated tfa procedure, the patient underwent laparoscopic dermoid cystectomy without spillage.While in the pacu, the patient noted significant lower abdominal pain and was admitted for pain control and evaluation.She also had urinary retention, with two post-void residuals of ~300 cc.She remains afebrile and without an elevated wbc.Ct scan is pending, and an indwelling foley was placed.(b)(6): this is not consistent with thermal injury to the bladder (no hematuria, fever or leukocytosis).The size of the fibroid placed the uterine serosa beyond the u/s depth and beyond the reach of the largest ablation with the sonata system.While the urinary retention could be secondary to general anesthesia, it seems somewhat prolonged for that to have been the etiology, and the pain is out of proportion, per dr.(b)(6) description, for either tfa or a laparoscopic ovarian cystectomy, especially given that the dermoid was not ruptured.(b)(6) 2024: i heard from treating physician: "the ct was basically unremarkable with post ablation changes.She eventually went home with a foley and was admitted 2 days postop for pain.It seemed like she just had poor pain control from the procedure.".

• 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: 22963987
• Report Number: 3005875675-2025-00053
• Device Sequence Number: 18455838
• 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: 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: 06/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LAPAROSCOPIC EXCISION.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 30 YR
• Patient Sex: Female