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

Model Number	TT0.25F6-450
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Localized Skin Lesion (4542)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The treatment tip was not retained for evaluation.A review of the datalogs showed that tuning, force, and activation errors occurred during treatment.Functional testing passed.Based on the evaluation of the data, the handpiece and system performed as expected.The user will want to verify that they are using adequate coupling fluid as they are performing treatments.The investigation is underway.
Event or Problem Description
A patient reported burns with scabbing to the lower side eyelid one day post a thermage flx eye treatment.During the treatment, the doctor performed 450 reps and used an eye shield with the highest energy level of 3 used.An error sound was heard 2-3 times during the treatment, but the treatment was able to be completed with no problems noted.The doctor was unsure what error message(s) were received.No other treatments besides thermage were being performed in the same symptom area, nor had any other treatments been performed in the symptom area within the prior thirty days.Solta medical cryogen and almost 30 ml of coupling fluid was used during the treatment.This was the initial use of the treatment tip, which was inspected prior to use and throughout the treatment with no anomalies noted.The treatment tip was not retained for evaluation.Three pictures labeled one day and two days after treatment were reviewed by the solta medical reviewer.It is not clear if the pictures are from one eye or both eyes.Burned areas and scabs are visible on the lower and upper eyelids.The patient was treated with neodex (steroids + antibiotics) ointment to prevent the scabs from becoming dry.The patient¿s current status noted that after two weeks, red marks remained.
Additional Manufacturer Narrative
Evaluation of the data log showed that the following errors occurred during treatment: quantity - error id - description - percent of reps.1 - ec781 - err_activation_button_timed_out - 0.22%.3 - ec78b - err_treatment_tip_force_low - 0.67%.6 - ed4c2 - err_gen_tuning_failure - 1.33%.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 data log confirmed provider¿s report of errors during treatment.The cause of ed4c2 (generator tuning failure), ec78b (low force), and ec781 (activation button timed out) errors is unknown as the treatment tip was unavailable for return.These event codes present no patient risk and could have been caused by user technique.A review of the manufacturing records showed all requirements were met.Final test verification specifications are acceptable.No nonconformities or anomalies found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.According to the thermage flx system user manual, burns are known possible adverse patient reactions to 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.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) AND ACCESSORIES
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI
• 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: 19671230
• Report Number: 3011423170-2024-00183
• Device Sequence Number: 6918107
• Product Code: GEI
• UDI-Device Identifier: 00816995021353
• UDI-Public: 00816995021353
• 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): 06/08/2024

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: TT0.25F6-450
• 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: 06/08/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2024
• 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: Unknown