MAUDE Adverse Event Report: GYNESONICS SONATA RADIOFREQUENCY ABLATION HANDPIECE; COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)

Model Number	RFA-002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Event or Problem Description
It was reported that during a patient underwent a sonata procedure on (b)(6) 2025, and was treated 10 days later for a bowel perforation.The initial procedure was performed concomitantly with dilation and curettage and the physician reported experiencing issues with dilation.It was determined at the time during an ultrasound that the patient´s posterior fibroid (approx.6cm) was displacing the endometrial cavity anteriorly.After successfully dilating the internal os, the physician was able to complete 2 ablations (3.9 x 3.2 and 3.5 and 2.6) with the sonata system.There were no perceived issues at the end of the procedure and the patient was sent home that day.Later the patient returned and a 1cm perforation of proximal ileus was observed.The pathology report showed that there was no significant spillage of succus, there was a fibrinous rind around the perforation and a six centimeter segment of small bowel resected and side to side functional end to end staple anastomosis was created.Bruising of the short segment of the proximal sigmoid colon was observed and no full thickness injury was identified at this area.Reminded of the sigmoid colon was healthy and without concern for injury.Inside the pelvis serosanguinous fluid was observed.No other information available.

• Brand Name: SONATA RADIOFREQUENCY ABLATION HANDPIECE
• Common Device Name: COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)
• 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102 ; CR 20102
• MDR Report Key: 24198943
• Report Number: 3005875675-2026-00001
• Device Sequence Number: 12139735
• Product Code: KNF
• UDI-Device Identifier: 10817929020371
• UDI-Public: 10817929020371
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K211535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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: RFA-002
• Device Catalogue Number: RFA-002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown