MAUDE Adverse Event Report: GYNESONICS SONATA DISPERSIVE ELECTRODE; ELECTROSURGICAL RETURN ELECTRODE

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	01/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The concomitant use of another electrosurgical device, in this case, an olympus monopolar resectoscope, was associated with placement of a proprietary olympus dispersive electrode on the side of one thigh near/adjacent to one of the paired gynesonics dispersive electrodes.The sonata ifu warns against simultaneous use of another electrosurgery device.The dispersive electrodes are single-use device and were discarded after the case.
Event or Problem Description
During a follow up on (b)(6) 2024, a patient returned to their gynecologist.A small papular lesion with what appeared to be a necrotic crutst on the right upper anterior thigh was noted, without surrounding erythema.This patient was treated with the company's sonata tfa system as well as operative hysteroscopy (monopolar resectoscopy) on (b)(6) 2024.Per the reported information by the treating physician, the sonata system dispersive electrodes (des) were placed near both patellae by the same experience team in the operating room.There were no issues note during the case, but it was also reported that the hysteroscopic light source was resting near the patient's upper thigh.Patient indicated that the lesion was not significantly symptomatic at this point.No information or pictures of the wound closer to the operative date but it was evident that the lesion was located in the location where the de and lamp were located.Per the provided picture taken at this follow up visit, the physician stated that the features are consistent with a 2nd degree burn.

• Brand Name: SONATA DISPERSIVE ELECTRODE
• Common Device Name: ELECTROSURGICAL RETURN ELECTRODE
• Manufacturer (Section D): GYNESONICS; 600 chesapeake drive; redwood CA 94063
• Manufacturer (Section G): GYNESONICS; 600 chesapeake drive; redwood CA 94063
• Manufacturer Contact: timothy rossi ; 600 chesapeake drive; redwood, CA 94063 ; 6502416115
• MDR Report Key: 18823064
• Report Number: 3005875675-2024-00002
• Device Sequence Number: 17274533
• Product Code: KNF
• UDI-Device Identifier: 10817929020364
• UDI-Public: (01)10817929020364(10)Y110921-05(17)241109
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

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: 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: IUSP-002 SONATA INTRAUTERINE ULTRASOUND PROBE.; OLYMPUS MONOPOLAR RESECTOSCOPE.; RFA-002 SONATA RADIOFREQUENCY ABLATION HANDPIECE.; SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM 2.2.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female