MAUDE Adverse Event Report: SOLTA MEDICAL INC. THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number	TT4.00F6-600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The data log from the event was reviewed.The data showed some tip too warm errors and premature tip lifting errors had occurred.Based on available data, the handpiece and system performed as expected.The treatment tip was requested for evaluation but has not been received.The investigation is ongoing.
Event or Problem Description
This report is related to 3011423170-2024-00134 (tt0.25f6-450, eye tip) both involving the same patient.A report was created for both the thermage flx eye tip and thermage flx face tip.As the injury was in the eye area, the suspect tip is the thermage flx eye tip in the related report.A user facility reported that a patient experienced a minor burn under their left eye following a thermage flx treatment.The patient received treatment to their face and eye areas.The highest level of treatment was at 3.0.It¿s unknown what brand of cryogen was used, and the amount of coupling fluid that was applied.No system errors occurred during the procedure.The treatment tip was inspected prior to use, and every 50 pulses during the procedure, with no discrepancies found.Approximately 30 days after treatment, the patient reported a minor burn under their left eye.It is not known if the patient received any other treatment in the symptom area on the procedure day or within 90 days prior.It is also unknown if they ever received treatment in the symptom area at any time in the past.The patient's current status and outcome is unknown.
Additional Manufacturer Narrative
The data log from the event was reviewed.The data showed some tip too warm errors and premature tip lifting errors had occurred.When the system detects a condition that interrupts treatment, a system error code is displayed.These system error codes provide an error code number and instructions for how to respond to the error.In the event of a system error, customers need to intervene to proceed.Based on the evaluation of the data, the handpiece and system performed as expected.The treatment tip was returned for evaluation.The tip passed leak and thermistor testing however failed visual inspection.A dent and excessive glue were found on the tip membrane.This would not cause risk to patient since radio-frequency energy is still able to distribute evenly across the membrane.No dielectric breakdown was observed.No functional test was performed due to tip being expired.According to thermage flx user manual, blisters are a known possible side effect during a thermage flx treatment.The procedure produces heating in the upper layers of the skin and may cause burns and subsequent blister and scab formation.There is a small chance of scar formation.Application of topical steroidal or antibiotic preparations may be of benefit.In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Review of manufacturing records show final manufacturing test verification specifications are acceptable.No nonconformities or anomalies were found related to this event when reviewing the device history record.Based on the available information, burns are a known potential reaction to treatment.No corrective action is necessary at this time.
Additional Manufacturer Narrative
This event no longer meets reportability requirements.The investigation and conclusions from our initial assessment remain unchanged.
Event or Problem Description
The patient received treatment for their burns and recovered with no permanent damage or scarring.No details of the burn treatment were provided.The solta medical reviewer determined that no serious injury had occurred.The event no longer meets reportability requirements.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• Common Device Name: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC.; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 18944761
• Report Number: 3011423170-2024-00133
• Device Sequence Number: 8208746
• Product Code: GEI
• UDI-Device Identifier: 00816995021421
• UDI-Public: 00816995021421
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K170758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2024

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 Model Number: TT4.00F6-600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/13/2024; 06/10/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 06/05/2024; 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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: TT0.25F6-450 SEE RELATED:3011423170-2024-00134
• Patient Sex: Unknown