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

Model Number	TT4.00F6-900
Medical Device Problem Codes	Noise, Audible (3273); Excessive Heating (4030)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060); Hyperpigmentation (4837)
Date of Event	02/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The treatment tip was given to the patient by the provider and is unavailable for evaluation.The data log from the event has been requested to be returned.The investigation is ongoing.
Event or Problem Description
A user facility reported that a patient experienced burns on their forehead along the hairline during a thermage flx treatment of the face and neck.It was observed during the procedure there were several minor burn areas on the forehead along the hairline.The forehead was cleansed, and silver sulfadiazine was applied to the affected areas.During the treatment, the clinic reported hearing a crackling sound.The system showed an error code of ec78c and displayed a warning that the tip was too warm.Solta medical branded cryogen and a ¿sufficient¿ amount of coupling fluid was used with the highest level of treatment at 2.0.This was the first time the treatment tip was used on a patient.It was inspected prior to use and throughout the procedure every time a ¿crackling sound¿ was heard.No discrepancies on the tip were found before or during the treatment.The treatment tip was not retained for evaluation.The patient had received skinbooster and picoplus laser treatment to the same symptom area within 90 days of the procedure date.No other treatments were performed in the same symptom area on the procedure date.A solta medical reviewer examined a photo taken three days post-procedure which showed multiple burns and crusting on the patient¿s forehead.The patient¿s status twelve days post-procedure was that the wounds had healed.An updated photo from this date was provided and examined by the solta medical reviewer.The photo showed the crusting has recovered, however, there is scar formation and post inflammatory hyperpigmentation.
Additional Manufacturer Narrative
The data log from the event was evaluated and several errors had occurred during treatment including; ec485-tip too cold, ec785-tip lifted prematurely, ec78b-tip force low, and the reported ec78c-tip too warm.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 system and handpiece performed as expected.Review of the errors indicated possible technique issues that could lead to inadequate cooling.The data log confirmed the customer¿s account of "tip too warm" errors occurring during the treatment.If a treatment tip¿s thermistors exceed the maximum temperature limit due to accelerated thermistor temperatures during active mode, the temperature monitor will catch this condition and display a ¿tip too warm¿ error and place the system into a safe state.This condition presents no patient risk.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.According to the thermage flx user manual, burns and hyperpigmentation known possible side effects 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.Based on the available information, no causal factors can be determined and no conclusions can be drawn.No corrective action is necessary at this time.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• Common Device Name: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 north creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 21608910
• Report Number: 3011423170-2025-00257
• Device Sequence Number: 18351085
• Product Code: GEI
• UDI-Device Identifier: 00816995021438
• UDI-Public: 00816995021438
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 02/18/2025

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: TT4.00F6-900
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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
• Patient Sex: Female