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 Burn (1756)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient received a sonata procedure on an unknown date, patient had come to the emergency room a few days after the procedure with pain and discomfort.Patient was diagnosed with thermal injury to the bowel which resulted in a small bowel resection.Patient was reported in good condition following the resection, and no further intervention was required.Additional information was received patient required resection and reanastomosis and the patient was doing fine and was released from the hospital.Physician reported that the ultrasound imaging was difficult to read due to the patient´s prior uterine artery embolization.Date of original procedure is unknown and no lot number available.
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.

• 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: 23597549
• Report Number: 3005875675-2025-00200
• Device Sequence Number: 18761306
• Product Code: KNF
• UDI-Device Identifier: 10817929020371
• UDI-Public: 10817929020371
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/19/2025

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: 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: 10/28/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown