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

Model Number TT4.00F6-900

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 01/16/2024

Event Type  Injury  

Event Description

A user facility reported a possible second degree burn to the patient's left jawline following a facial thermage flx treatment.The patient was treated with an artificial skin graft and given an ice pack.The patient did not apply anything over the counter at home to treat the burn.The current status is reported that the blisters are resolving with no permanent scar expected.However, it is noted that post inflammatory hyperpigmentation is expected.An available picture was reviewed by the medical reviewer and a large blister is visible under the skin graft on the jawline.The patient was administered iv anesthesia and unable to supply feedback during the treatment.No other treatments (besides the one reported) were being performed in the same area where symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 90 days.The patient has had prior thermage flx aesthetic treatments on this area.The incident occurred at about 900 reps.The highest energy level used was 3.5j.No system errors occurred nor did anything out of the ordinary occur during treatment.A stamping method was used.Solta cryogen and 40 ml of unscented coupling fluid were used.The treatment tip surface was inspected prior to use and nothing remarkable observed.The treatment tip surface was inspected during the treatment at about every 3-4 pulses.This treatment tip has not been used on any other patients.

Manufacturer Narrative

The datalogs were reviewed and based on the evaluation of the data, the system and handpiece perform as expected.Cryogen did flow to the treatment tip, but the system posted ec78c because to the handpiece had been tilted during the treatment.Thermistor data clearly showed that on the first half to the treatment the handpiece was tilted on the right side.Thermistors at the higher position received less cryogen and became warmer and triggered ec78c compared to the lower position thermistors.On the other hand, the second half of the treatment the hp was tiled on the opposite side.Quantity: 40, error id: ec78c, description: err treatment tip temp high, percent of reps: 4.44%.Quantity: 8, error id: ec785, description: err treatment tip lifted prematurely, percent of reps: 0.89%.Quantity: 1, error id: ec78e, description: err force before activation, percent of reps: 0.11%.The treatment tip has been requested.The investigation is underway.

Manufacturer Narrative

Evaluation of the data log confirmed system and handpiece performed as expected.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.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, the user needs to intervene and follow the onscreen instructions to proceed with treatment.The treatment tip was returned and evaluated.The tip passed the leak and thermistor test.The tip also passed visual inspection as no dents, scratches, blemishes, or dielectric breakdown was observed.No functional test was performed due to tip being expired.No issues were found during the evaluation of the tip.According to the thermage flx system user manual, burns and blisters 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.The thermage flx user manual cautions user to not use local injections or tumescent anesthetic or nerve block techniques to manage patient comfort during the thermage procedure.Use of these types of pain management techniques increases the risk of tissue injuries.A review of manufacturing records showed all requirements were met.No non-conformities 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 were considered acceptable, with the product performing within anticipated rates.Based on the available information, burns and blisters are known possible adverse patient reactions to thermage flx.At this time, no capa is necessary.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• Type of Device: 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: 19032957
• MDR Text Key: 339251395
• Report Number: 3011423170-2024-00139
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00816995021438
• UDI-Public: 00816995021438
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

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
• Device Operator: Health Professional
• Device Model Number: TT4.00F6-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female