MAUDE Adverse Event Report: GYNESONICS SONATA DISPERSIVE ELECTRODES

Model Number	DE-001
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was one of three events reported together from the same site to the manufacturer.The three events occurred over the course of 10 months when the system was also used without issue.The case was completed using the sonata system 2.0 utilizing dispersive electrode lot 100321.The dispersive electrodes are single-use and were discarded after the case.To date, no other site has reported any incidence of burns.Review of the system manufacturing and use records for this case did not identify issues with the radiofrequency generator, the smart tablet, intrauterine ultrasound probe or radiofrequency ablation handpiece.A review of the manufacturing records and examination of retained samples from the same lot of dispersive electrodes have not shown any product deficiencies.Interviews and communications with site personnel have identified site-specific practices that may have contributed to this incident.An investigation to reproduce the issue shall be completed and a follow-up report will be submitted once the investigation is finalized.
Event or Problem Description
On november 14, 2020 a doctor reported that a patient had experienced potential skin burns after use of the sonata system.After removal of the dispersive electrodes (de), the doctor observed that the patient's skin on one leg, at the edge of the de application location, appeared to be very warm and red.The physician stated that hospital staff sometimes cleaned the patient's skin before placing the dispersive electrodes.The doctor reported that it is unknown if the dispersive electrodes were wet or placed correctly by the hospital staff.The event occurred on (b)(6) 2019.On nov 18, 2020 the doctor reported that the burn wound was a second-degree burn and was noted after removal of one of the dispersive electrodes.The patient was treated with topical ointment lalugen plus creme (hylaronic acid, sulfadiazine silver) and recovered uneventfully.On dec 3, 2020, it was noted that an electrical blanket was used to warm the patient during the procedure.
Additional Manufacturer Narrative
This case was one of three events reported together from the same site to the manufacturer.Please see mfr report #: 3005875675-2020-00001 and mfr report #: 3005875675-2020-00003.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.Additional information was received from customer indicating that this was a use error and the hospital staff has been retrained on the correct application of the dispersive electrodes.Possible causative factors for an increase in temperature at site of application of the dispersive electrode (de) were identified and documented through fishbone analysis and included device deficiency; contact of de with substances or devices; and improper application of the de by the user.Initial investigation of potential causative factors included inspection of retained de samples from the same lot and inspection of the sonata system at the customer location including review of data obtained from the system log.Potential causative factors that could not be excluded based on results of the initial investigation and/or information from the customer were then evaluated further with testing conducted with retained de samples using liver as a surrogate for skin to measure temperature rise under the potential cause conditions.Potential causative factors that did not result in any temperature rise, or that resulted in a temperature rise well below the rise necessary to result in skin burn were eliminated as a potential root cause.Misapplication of the de resulting in insufficient adhesion of the hydrogel to the skin is the sole potential causative factor that is consistent with the results of the investigation including 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 ELECTRODES
• Common Device Name: DISPERSIVE ELECTRODES
• Manufacturer (Section D): GYNESONICS; 600 chesapeake drive; redwood city CA 94063
• MDR Report Key: 10998594
• Report Number: 3005875675-2020-00002
• Device Sequence Number: 13625848
• Product Code: KNF
• UDI-Device Identifier: 10817929020005
• UDI-Public: 10817929020005
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2020

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 Expiration Date: 07/13/2021
• Device Model Number: DE-001
• Device Catalogue Number: DE-001
• Device Lot Number: 100321
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2020
• Supplement Date Received by Manufacturer: 01/31/2021
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SONATA 2-220, SONATA SYSTEM 220V; SONATA CASE KIT WITH RFA HANDPIECE; SONATA INTRAUTERINE ULTRASOUND PROBE
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 54