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

Model Number	TT16.00F6-500
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Codes	Erythema (1840); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694); Blister (4537); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the datalogs confirmed that ¿tip too warm¿ errors occurred during the treatment.Based on the evaluation of the data, the handpiece and system performed as expected.Liquid cryogen appeared to be flowing to the treatment tip.The user will want to verify proper treatment technique, position and orientation (with adequate coupling fluid and equal tip to skin contact and pressure).The treatment tip has been returned and is pending evaluation.Further investigation is underway.
Event or Problem Description
A user facility reported patient burns during a thermage flx treatment of the thighs.Both thighs were burnt and swollen, and the left thigh had blisters.The nature of burn was reported as first degree, superficial redness and swelling, and second degree burn with minor blisters.The patient was under intravenous propofol during the treatment.No other treatments besides thermage were performed in the same area at the time of the event or for the previous ninety days.The incident occurred after the 500th rep.The treatment highest energy level of 5 was used during the treatment.¿tip too warm¿ errors reportedly occurred during the treatment.The treatment was performed with a stamping method and 40 milliliters of solta coupling fluid.The treatment tip was inspected at the onset of treatment and every fifty pulses throughout, with no anomalies noted.The patient's burns were treated with sulfadiazine silver.Permanent damage or scarring is expected.Pictures of the patient¿s thighs were reviewed by the solta medical reviewer.It is not clear if all three pictures are from one side or not.Erythema and inflammation with multiple blisters are visible on patient's thigh.
Additional Manufacturer Narrative
The following error codes were identified in review of the datalogs: quantity - error id - description - percent of reps: 6 - ec78b - err_treatment_tip_force_low - 1.20% 3 - ec781 - err_activation_button_timed_out - 0.60% 23 - ec78e - err_force_before_activation - 4.60% 12 - ec78c - err_treatment_tip_temp_high - 2.40% 5 - ec485 - err_treatment_tip_too_cold - 1.00% 5 - ec785 - err_treatment_tip_lifted_prematurely - 1.00%.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 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.Tip too warms errors could have been caused by user technique.The treatment tip was returned for evaluation.The tip passed leak and thermistor testing, as well as visual inspection.No dents, scratches, blemishes, or dielectric breakdown was observed.No functional test was able to be performed due to tip being expired.A review of the manufacturing records showed all requirements were met.Final test verification specifications are acceptable.No nonconformities or anomalies were 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 thermage flx system user manual, burns, blisters, swelling, and redness 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.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.Swelling may occur and typically resolves within 5 days but can persist up to several weeks.Erythema (redness) may occur in mild form and typically resolve within a few hours.However, on rare occasions, erythema has been reported to last longer (up to several weeks).Based on the available information, burns, blisters, swelling, and redness are known possible adverse patient reactions to thermage flx treatment.No corrective action is necessary at this time.
Event or Problem Description
The patient was instructed to use dressing and hyperbaric oxygen therapy.Heat or ice and over-the-counter treatments were applied at home by the patient.

• 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: 19290569
• Report Number: 3011423170-2024-00157
• Device Sequence Number: 7130563
• Product Code: GEI
• UDI-Device Identifier: 00816995021360
• UDI-Public: 00816995021360
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 04/10/2024

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: TT16.00F6-500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• 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
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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: Unknown