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 device was discarded.The investigation is underway.
Event or Problem Description
A user facility reported a burn to the face a few days post thermage flx treatment.No secondary interventions was required to treat this event.It is unknown what the patient's current status also if there will be any permanent scarring.An available photo was reviewed and was determined that a wound is visible on the right side of the patient's cheek that appeared to be a burned area.The status of the wound is not clear due to low quality of the picture.No other treatments besides thermage were being performed in same area where symptoms were reported.It is unknown if the patient undergone any other treatments in the same symptom area within the past 30 days.The incident occurred after 900 reps, the highest energy used was 2~2.5 j.A tip too warm error message occurred during treatment.Solta medical croygen and coupling fluid (almost 30ml) was used during this treatment.The treatment tip surface was inspected prior to use and nothing was observed.The treatment tip was reinspected during treatment at about every 50 reps.This is the first time the treatment tip was used.The treatment tip was discarded.
Event or Problem Description
The doctor declined to provide additional information.
Additional Manufacturer Narrative
The treatment tip was not returned for evaluation as it was discarded by the reporting facility.The data log was reviewed and the following errors occurred during treatment: quantity: (b)(4), error id - ec485, description - err treatment tip too cold - percent of reps: 1.34%.Quantity: (b)(4), error id - ec785, description - err treatment tip lifted prematurely - percent of reps: 1.84%.Quantity: (b)(4), error id - ec78b, description - err treatment tip force low - percent of reps: 0.34%.Quantity: (b)(4), error id - ec78c, description - err treatment tip temp high - percent of reps: 4.86%.Quantity: (b)(4), error id - ec78e, description - err force before activation - percent of reps: 0.34%.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 the user to respond to the error.In the event of a system error, the user needs to intervene to proceed.Based on the evaluation of the data, the handpiece and system performed as expected.The data 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.According to thermage flx user manual, burns 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.Based on the evaluation of the data, the handpiece and system performed as expected.The treatment tip was not returned for investigation.Based on the available information, no causal factors can be determined, and no conclusions can be drawn.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.At this time, no corrective action is necessary.
Additional Manufacturer Narrative
Correction: investigation findings from 213 to 4256.No nonconformities or anomalies were found related to this event when reviewing the device history record.The conclusions from the previous report submission remain unchanged.

• 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; ste. 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 18991807
• Report Number: 3011423170-2024-00138
• Device Sequence Number: 3038215
• 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,Followup
• Report Date (Section B): 03/04/2024

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: Not provided; 05/22/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/17/2024; 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• 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
• Patient Sex: Male