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

Device Problems Energy Output Problem (1431); Excessive Heating (4030)

Patient Problems Burn(s) (1757); Erythema (1840); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 01/18/2024

Event Type  Injury  

Event Description

A user facility reported that a patient was burned on the face under the eye during a flx treatment after a "tip too warm" message appeared.The patient experienced redness, swelling and water vacuole under eye after a procedure on the same area.No secondary intervention (ointments, medications, etc.) was required to treat the burn.The current status was described as redness and burn, with the outcome unknown.The first available picture was reviewed by the medical reviewer and mild erythema and blisters are visible under the eye.A second available picture was also reviewed, and blisters are resolved to scab with erythema and one hyperpigmented area is visible under the same eye.It is reported that the energy output seemed more intense than normal.The customer temporarily paused the treatment, and then the "tip too warm" message cleared after the customer changed the coolant canister and waited several minutes for the tip to cool down.The energy setting was lowered before proceeding.The customer used the same tip throughout the entire face treatment.A black eye shield was used.The patient was not administered any pain medication or placed under anesthesia.No other treatments (besides the one reported) were being performed in the same area where the symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 90 days, nor has the patient ever had prior aesthetic treatments on this area.The highest energy level used was 3.5 j.Solta cryogen and unscented coupling fluid were used.The treatment tip surface was not inspected prior to use, nor was it re-inspected during treatment.The tip has not been used on any other patients.The tip has been discarded.

Manufacturer Narrative

The thermage flx treatment tip was discard and can't be evaluated.The datalogs were returned and evaluated and showed the following errors: quantity - error id - description - percent of reps 2 - ec785 - err_treatment_tip_lifted_prematurely - 0.22% 2 - ec78b - err_treatment_tip_force_low - 0.22% 1 - ec78c - err_treatment_tip_temp_high - 0.11% 12 - ec78e - err_force_before_activation - 1.33%.Based on the evaluation of the data, the handpiece and system performed as expected.Based on the data log after 75 shots, the cryogen can had been replaced and after 3 minutes the treatment was resumed.It is recommended to start every treatment with a new cryogen can.If the cryogen can was replaced, it is recommended to wait at least 10 minutes before continuing the treatment to allow the cryogen to refill and for the system to stabilize.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should the system be outside of acceptable limits.The review of the system/data logs does not indicate there is any handpiece or system issue present.The investigation is ongoing.

Manufacturer Narrative

The datacard log confirmed the customer¿s account of "tip too warm" error occurring during treatment.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.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.It is unknown what caused the errors since no tip was returned for evaluation.Based on the evaluation of the data, the system and handpiece perform as expected.According to thermage flx user manual, burns and swelling are known possible side effects 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.A review of the manufacturing records showed all requirements were met.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, no causal factors can be determined with this event and no conclusions can be drawn.No corrective action is necessary.

Manufacturer Narrative

Correction: type of investigation from 3331 to 4109.Correction: investigation findings from 213 to 3221.Correction h10/11 narrative: remove "a review of manufacturing requirements were met" and add "as no product serial number was provided, a manufacturing record review was unable to be performed.".

• 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 n 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: 18707253
• MDR Text Key: 335405568
• Report Number: 3011423170-2024-00125
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/13/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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