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 2.1 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.
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On (b)(6) 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) 2020.On (b)(6) 2020, the doctor also reported that based on the information provided, a cleaning solution benzin medizinal (wound benzin) was used to clean the anterior thigh of the patient's leg prior to application of the dispersive electrode.The doctor reported that the dispersive electrode adhesive appeared to have partially separated from the electrode covering.The doctor reported that the burn was a second degree burn in one leg.The patient was managed with topical therapy lalugen plus crème (hylaronic acid, sulfadiazin silver) and recovered uneventfully.On (b)(6) 2020, it was noted that an electrical blanket was used to warm the patient during the procedure.
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