MAUDE Adverse Event Report: GYNESONICS, INC. SONATA DISPERSIVE ELECTRODE; ELECTROSURGICAL RETURN ELECTRODE, SINGLE-USE

Model Number	DE-001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, gynecologist coordinator reported to gynesonics clinical specialist that a patient had experienced a skin burn after use of the sonata system.The picture showed that piece of the outer skin layer came off.Coordinator indicated that this occurred to only one side and the skin around the tear was red and hot to the touch.About an hour later, clinical specialist received additional information, the nurse had taken a picture and she indicated that it was not a burn but the skin had been pulled off and it was most likely due to the adhesive of the dispersive electrode.On (b)(6), 2023, gynesonics clinical specialist received additional information from the doctor, he indicated that after the patient's post-operative appointment on (b)(6) 2023, the patient seem doing overall very well and her skin burn was treated with peroxide and antibiotic ointment.Doctor, also indicated that the patient had another minor skin blistering on the other leg.
Additional Manufacturer Narrative
The dispersive electrodes are single-use device and were discarded after the case.Root cause investigation is ongoing and addition information will be provided during the follow-up report.
Event or Problem Description
On (b)(6) 2023, gynecologist coordinator reported to gynesonics clinical specialist that a patient had experienced a skin burn after use of the sonata system.The picture showed that piece of the outer skin layer came off.Coordinator indicated that this occurred to only one side and the skin around the tear was red and hot to the touch.About an hour later, clinical specialist received additional information, the nurse had taken a picture and she indicated that it was not a burn but the skin had been pulled off and it was most likely due to the adhesive of the dispersive electrode.On march 21, 2023, gynesonics clinical specialist received additional information from the doctor, he indicated that after the patient's post-operative appointment on (b)(6) 2023, the patient seem doing overall very well and her skin burn was treated with peroxide and antibiotic ointment.Doctor, also indicated that the patient had another minor skin blistering on the other leg.
Additional Manufacturer Narrative
The dispersive electrodes are single-use device and were discarded after the case.A review of the manufacturing records and examination of retained samples from the same lot of dispersive electrodes have not shown any product deficiencies.Misapplication of the de resulting in insufficient adhesion of the hydrogel to the skin is the root cause of the temperature rise sufficient to result in a skin burn.The sonata system operator's manual (instructions for use) includes instructions for application of dispersive electrodes as well as relevant warnings.Use error is therefore determined to be the root cause.

• Brand Name: SONATA DISPERSIVE ELECTRODE
• Common Device Name: ELECTROSURGICAL RETURN ELECTRODE, SINGLE-USE
• Manufacturer (Section D): GYNESONICS, INC.; 600 chesapeake drive; redwood city CA 94063
• Manufacturer (Section G): GYNESONICS; 600 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: timothy rossi ; 600 chesapeake drive; redwood, CA 94063 ; 6502416115
• MDR Report Key: 16686776
• Report Number: 3005875675-2023-00002
• Device Sequence Number: 5922040
• Product Code: KNF
• UDI-Device Identifier: 10817929020364
• UDI-Public: (01)10817929020364(10)Y110921-05(17)241109
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 11/09/2024
• Device Model Number: DE-001
• Device Catalogue Number: DE-001-10
• Device Lot Number: Y110921-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM 2.2; SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM 2.2
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female