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

Model Number TT4.00F6-900

Device Problem Excessive Heating (4030)

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 10/30/2023

Event Type  Injury  

Manufacturer Narrative

The treatment tip has been requested for evaluation.The investigation is underway.

Event Description

It was reported that a patient experienced second degree burns with blisters on both cheeks during a thermage flx facial treatment.Ec78c errors (tip too warm) were received during the treatment.The burns were observed at 700 reps and the highest energy level used was 4.Solta medical cryogen and 75 ml solta coupling fluid were used during the treatment.This treatment was the initial use of the treatment tip.The treatment tip was inspected prior to use and every two pulses during the treatment, with nothing atypical noted.The patient was administered iv anesthesia during the treatment.No other treatments were being performed in the symptom area, nor were any other facial treatments performed in the previous 90 days.The patient had not had prior aesthetic facial treatments.Secondary intervention to treat the burns include tr5, b12, zinc, deca0, suwell, and fucdin.The patient is currently continuing wound care.The reporting doctor does not believe there will be any permanent damage or scarring.Patient pictures were reviewed by the solta medical reviewer, who noted that the first picture labeled during the procedure shows large areas of erythema and inflammation with blisters on upper cheek.The second picture labeled after treatment shows large area of erythema with inflammation subsided and blisters on both upper and lower part of the cheek.Two pictures are labeled a day after the procedure.One shows large inflammation and erythema and multiple blisters; however, the other picture shows only erythema with mild inflammation and small blisters.After careful review of the available pictures, it is clear that the patient needs treatment beyond standard of care to recover and a full recovery without a permanent scar is not certain.

Manufacturer Narrative

The datalogs for this treatment have been reviewed.The following error messages occurred during the treatment: 2 - ec485 - err_treatment_tip_too_cold - 0.22%.3 - ec785 - err_treatment_tip_lifted_prematurely - 0.33%.27 - ec78c - err_treatment_tip_temp_high - 3.00%.Based on the evaluation of the data, the system and hp perform as expected.The user will want to verify proper treatment technique, position and orientation (with adequate coupling fluid and equal tip to skin contact and pressure).Cryogen appeared to be flowing during the treatment.The investigation is ongoing.

Manufacturer Narrative

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 system performed as expected.The datacard log confirmed the customer¿s account of ''tip too warm errors'' 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.It is unknown what caused the error during treatment, but a user technique issue is possible.According to the thermage flx user manual, burns are a known possible side effect during thermage flx treatments.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 lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.A review of the manufacturing records showed that all requirements were met.No nonconformities or anomalies were found related to this complaint when reviewing the device history record.Final test verification specifications are acceptable.Evaluation of the treatment tip found no issues related to this event.Datacard log evaluation showed the system and handpiece perform as expected.Based on the available information, the most probable root cause is that burns are a known possible side effect during a thermage flx treatment.No corrective action is necessary at this time.

Manufacturer Narrative

The treatment tip was returned for evaluation with zero treatment reps left available.The tip passed the leak test and the thermistor test.As no dents, scratches, blemishes, or dielectric breakdown were observed on the tip, it passed visual inspection.Functional testing was not able to be performed due to the tip being expired.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.The review of the system/data logs does not indicate there is any handpiece or system issue present.Further investigation is underway.

• Brand Name: THERMAGE FLX (TG-3A) AND ACCESSORIES
• Type of Device: 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: 18184844
• MDR Text Key: 328741791
• Report Number: 3011423170-2023-00099
• Device Sequence Number: 1
• Product Code: GEI
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• 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?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2023
• 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