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 Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded.The investigation is ongoing.
Event or Problem Description
A user facility reported a burn to the face a few days after a thermage flx treatment.The area of the body was that was treated was the face.No secondary intervention (ointments, medications, etc.) was required to treat this event.Due to limited information, it is unknown if there will be any damage or scarring.An available picture was reviewed.A wound is visible on temporal area.The exact status of the wound is not clear due to low quality of the picture.No other treatments (besides thermage) were being performed in the same area where the symptoms were reported.It is unknown if the patient has undergone any other treatments in the same symptom area within the past 30 days.The incident is reported to have occurred after 900 reps.The highest energy level used was 2-2.5 mj.A tip too warm error was generated during treatment.Solta medical croygen and 30ml of coupling fluid were used during this treatment.The treatment tip surface was inspected prior to use and there was nothing remarkable.The treatment tip surface was inspected about 50 reps during the treatment.This is the first time this treatment tip was used.The treatment tip was not kept for return.
Additional Manufacturer Narrative
Correction 5.From: labeled for single use? no to yes.The product was not returned for investigation.The datacard log was returned and reviewed.Datacard logs showed the following errors occurred during treatment: quantity: 3 - error id: ec785 - description: err_treatment_tip_lifted_prematurely - percent of reps: 0.50%.Quantity: 1 - error id: ec78b - description: err_treatment_tip_force_low - percent of reps: 0.17%.Quantity: 4 - error id: ec78c - description: err_treatment_tip_temp_high - percent of reps: 0.67%.Quantity: 10 - error id: ec78e - description: err_force_before_activation - percent of reps: 1.67%.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.The datacard log confirmed the customer¿s account of tip too warm error occurring during 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.Based on the evaluation of the data, the system and handpiece perform as expected.According to thermage flx system user manual, burns are known possible side effects of 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.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the available information, no causal factors can be determined, and no conclusions can be drawn.At this time, no capa is necessary.
Event or Problem Description
Information concerning the outcome of the patient was requested and the clinic declined to provide any information related to the patient.

• 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; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 19125967
• Report Number: 3011423170-2024-00144
• Device Sequence Number: 8229867
• Product Code: GEI
• UDI-Device Identifier: 00816995021438
• UDI-Public: 00816995021438
• 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
• Report Date (Section B): 03/20/2024

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: TT4.00F6-900
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown