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 Code	Unspecified Reproductive System or Breast Problem (4513)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is nothing in the initial report to confirm a bowel injury, just a thermal effect on the posterior external cervical os and vaginal fornix without involvement of the internal cervical os.Of the two, the potential thermal injury of the fornix is the only area that conceivably could impact the bowel (the external os is not anywhere in contact with the peritoneal cavity, whereas the upper vaginal vault certainly is).A bowel injury can't be ruled out in the absence of further information, but the current diagnosis seems to be a thermal burn to the external os and a portion of the vault.Without additional information, it is not clear what the proximate cause of this injury would have been.While there was no obvious device malfunction per the treating physician's report, final confirmation would be pending a complete analysis of the treatment device used in this case.
Event or Problem Description
On (b)(6) 2025, it was initially reported to gynesonics by treating physician that she performed transcervical fibroid ablation (tfa) with the sonata® system concomitantly with a hysteroscopic myomectomy with a myosure® reach device, omni® hysteroscope with a fluent fluid management system, and also a d&c procedure.Towards the end of the tfa procedure, the treating physician noticed a blanched area on the posterior lip of the external cervical os that had some char.The area was noted at the 6 to 9 o'clock position on the external os and was a few centimeters in size and she also noted a small area in the vaginal fornix that was blanched and a small area that was "denuded." these areas were noted after the physician had completed 4 fibroid ablations with the sonata device.The sonata device was used following an unremarkable hysteroscopic myomectomy of a small anterior fibroid and a d&c procedure.A diagnostic hysteroscopy was performed after observing this blanched area, doctor did not note any thermal injury involving the endocervical canal.The patient was stable at the end of the procedure, given antibiotics and doctor did have her transferred to (b)(6) hospital for observation because she was not able to determine the depth of the thermal spread which could potentially have involved nearby viscera.On september 04, 2025, we received additional information from the physician, she indicated that images were taken of the affected external areas, but we do not have those images to review, nor the case video.She was also informed by a third party that a thermal bowel injury did occur, but she does not know the patient's current status.Her use of the term "denuded" specifically indicates that a superficial layer of the vaginal tissue was somehow mechanically injured or removed.She was not sure if that was a result of the nearby thermal damage.Two separate fibroids were treated.She does not recall the exact measurements.The first of the four ablations was performed in fibroid 1, it was intramural figo type 4, small in size, <2cm.The other 3 ablations were performed on fibroid number 2, it was a larger fibroid >3-4cm, but the specific dimensions are not indicated.It was also intramural, or possibly transmural and posterior, in the mid-body to lower uterine segment proximal to the cervix.The sonata device did not have any malfunctions of which she was aware.On (b)(6) 2025 we were notified that the patient was discharged from the hospital the week prior.
Additional Manufacturer Narrative
Results from investigation: the initial report didn't contain any information to confirm a bowel injury or that a device malfunction occurred.The actual device used for treatment in this case was received back and tested.Also the case video was reviewed by internal experts.These activities were completed on 11/17/2025.The results of that analysis are as follows: the rfa handpiece used in this case was received dirty but was in good physical condition with both electrodes and introducer intact.The tine spread mew measurements between the electrode pairs are within specifications.There is no damage to introducer or device shaft.Mechanically the handpiece functions as intended.Review of case video did not show any error codes suggesting there was a device failure.The ramp time to treatment temperature for the four ablations was 41 s, 45 s, 51 s, and 44 s.All are close to nominal value (45 seconds) and do not suggest that power was lost to a "satellite" ablation produced by insulation defects.The handpiece investigation shows no sign of damage to the handpiece and that it functioned as intended.Thus the conclusion to the investigation is that no problem with the device was dented that could have caused the reported adverse event.
Event or Problem Description
On oct.28, 2025, we received the following additional information about this patient.The physician reported that the patient required a colostomy bag.The physician reported that she had followed up with the patient approximately a month before this contact and the patient still had a colostomy in place.The patient was hopeful that she would have a reversal but at the time that reporting physician saw her, that had not yet happened.She said that the patient was otherwise stable.
Additional Manufacturer Narrative
Results from investigaion: the initial report didn't contain any information to confirm a bowel injury or that a device malfunction occurred.The actual device used for treatment in this case was recevied back and tested.Also, the case video was reviewed by internal experts.These activities were completed on 11/17/2025.The results of that analysis are as follows: the rfa handpiece used in this case was received dirty but was in good physical condition with both electrodes and introducer intact.The tine spread mew measurements between the electrode pairs are within specifications.There is no damage to introducer or device shaft.Mechanically the handpiece functions as intended.Review of case video did not show any error codes suggesting there was a device failure.The ramp time to treatment temperature for the four ablations was 41 s, 45 s, 51 s, and 44 s.All are close to nominal value (45 seconds) and do not suggest that power was lost to a "satellite" ablation produced by insulation defects.The handpiece investigation shows no sign of damage to the handpiece and that it functioned as intended.Thus, the conclusion to the investigation is that no problem with the device was dected that could have caused the reported adverse event.
Event or Problem Description
On aug 27, 2025, it was initially reported to gynesonics by treating physician that she performed transcervical fibroid ablation (tfa) with the sonata® system concomitantly with a hysteroscopic myomectomy with a myosure® reach device, omni® hysteroscope with a fluent fluid management system, and also a d&c procedure.Towards the end of the tfa procedure, the treating physician noticed a blanched area on the posterior lip of the external cervical os that had some char.The area was noted at the 6 to 9 o'clock position on the external os and was a few centimeters in size and she also noted a small area in the vaginal fornix that was blanched and a small area that was "denuded." these areas were noted after the physician had completed 4 fibroid ablations with the sonata device.The sonata device was used following an unremarkable hysteroscopic myomectomy of a small anterior fibroid and a d&c procedure.A diagnostic hysteroscopy was performed after observing this blanched area, doctor did not note any thermal injury involving the endocervical canal.The patient was stable at the end of the procedure, given antibiotics and doctor did have her transferred to riverside hospital for observation because she was not able to determine the depth of the thermal spread which could potentially have involved nearby viscera.On september 04, 2025, we received additional information from the physician, she indicated that images were taken of the affected external areas, but we do not have those images to review, nor the case video.She was also informed by a third party that a thermal bowel injury did occur, but she does not know the patient's current status.Her use of the term "denuded" specifically indicates that a superficial layer of the vaginal tissue was somehow mechanically injured or removed.She was not sure if that was a result of the nearby thermal damage.Two separate fibroids were treated.She does not recall the exact measurements.The first of the four ablations was performed in fibroid 1, it was intramural figo type 4, small in size, <2cm.The other 3 ablations were performed on fibroid number 2, it was a larger fibroid >3-4cm, but the specific dimensions are not indicated.It was also intramural, or possibly transmural and posterior, in the mid-body to lower uterine segment proximal to the cervix.The sonata device did not have any malfunctions of which she was aware.On september 16, 2025, we were notified that the patient was discharged from the hospital the week prior.

• 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: 23124372
• Report Number: 3005875675-2025-00070
• Device Sequence Number: 17990595
• Product Code: KNF
• UDI-Device Identifier: 10817929020326
• UDI-Public: (01)10817929020326(11)241111
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K250705
• 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,Followup,Followup
• Report Date (Section B): 11/26/2025

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: 08/27/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 08/27/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/25/2025; 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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 WITH MYOSURE REACH.; HYSTEROSCOPIC MYOMECTOMY WITH MYOSURE REACH.; HYSTEROSCOPIC MYOMECTOMY WITH MYOSURE REACH.; OMNI AND FLUENT AND A D&C.; OMNI AND FLUENT AND A D&C.; OMNI AND FLUENT AND A D&C.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female