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	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On march 9, 2023, a doctor reported to gynesonics clinical specialist that a patient had experienced potential skin burns after use of the sonata system on (b)(6) 2023.During the patient post operative follow up visit 3 weeks after the sonata system procedure, doctor indicated that there was a mark on the patient's leg potentially caused by the dispersive electrode.Doctor indicated that it could be a skin burn.On march 13, 2023, gynesonics clinical specialist reached out to doctor to attempt to gather more information on this event.Doctor indicated that the patient mentioned in post op that she had a red mark.Patient indicated that during the next few days, she had some redness/blistering type irritation in the area.Gynesonics' personnel became aware of this incident on march 09, 2023 after the patient follow up visit.
Additional Manufacturer Narrative
The dispersive electrodes are single-use device and were discarded after the case.Root cause investigation is ongoing and additional information will be provided during the follow-up report.
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.
Event or Problem Description
On (b)(6) 2023, a doctor reported to gynesonics clinical specialist that a patient had experienced potential skin burns after use of the sonata system on (b)(6) 2023.During the patient post operative follow up visit 3 weeks after the sonata system procedure, doctor indicated that there was a mark on the patient's leg potentially caused by the dispersive electrode.Doctor indicated that it could be a skin burn.On (b)(6), 2023, gynesonics clinical specialist reached out to doctor to attempt to gather more information on this event.Doctor indicated that the patient mentioned in post op that she had a red mark.Patient indicated that during the next few days, she had some redness/blistering type irritation in the area.Gynesonics' personnel became aware of this incident on (b)(6), 2023 after the patient follow up visit.

• 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: 16686773
• Report Number: 3005875675-2023-00001
• Device Sequence Number: 14933051
• Product Code: KNF
• UDI-Device Identifier: 10817929020364
• UDI-Public: (01)10817929020364(10)Y110921-05(17)241109
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 03/09/2023
• 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