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 Temperature Problem (3022)

Patient Problems Erythema (1840); Inflammation (1932); Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 08/09/2023

Event Type  malfunction  

Event Description

A user facility reported a minor second degree burn with several red and swollen spot-like little blisters over the patent's' cheek post thermage flx treatment.Topical analgesic was used during the treatment.It is reported that the patient was given bg cream to treat the symptoms.The reporter indicated that the blisters are resolving and that there will not be any permanent damage or scarring.The medical reviewer examined the provided information as well as the provided patient pictures.Two pictures showed multiple crusts scattered on cheeks.One picture shows small crusts on the lower side of the cheek.The medical reviewer deemed this case not serious, as the information did not suggest a serious injury occurred.The system error ec78c (treatment tip temp high) was reported to have occurred during the treatment.The incident reportedly occurred at around 900 reps with energy level 3.Solta medical cryogen and around 30ml of solta coupling fluid were used during the treatment.This treatment was the initial use of the treatment tip, and the tip was inspected prior to use but not throughout the treatment.The treatment tip was returned and evaluated.Upon inspection, solta medical identified dielectric breakdown of the tip membrane, which is a reportable malfunction for thermage due to the potential for patient injury.

Manufacturer Narrative

The data logs were collected and reviewed.Based on the evaluation of the data, the handpiece and system performed as expected.The datacard log confirmed that the tip too warm error ec78c occurred during treatment.It is possible this error was caused by user technique, but it is unknown.The logs also showed that there was an error indicating that the treatment tip was lifted prematurely.It is recommended for the user to verify proper treatment technique, position and orientation (with adequate coupling fluid and equal tip to skin contact and pressure).The handpiece needs to be perpendicular to the ground in the time of the 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.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 treatment tip was also returned and evaluated.The tip passed the leak and thermistor tests.The tip failed visual inspection for a pin hole and a scratch on the tip surface.Dielectric breakdown was observed around the pinhole and scratch area.No functional was able to be performed due to the tip being expired and used up.Breakdown of the tip membrane can cause the radiofrequency energy, delivered by the system, to focus in a small area of the membrane, rather than to be uniformly distributed over the entire membrane area, potentially causing patient burns.According to the thermage flx user manual, blisters, redness, and swelling are known possible side effects during a 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 lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.Based on the evaluation of the data, the system and handpiece perform as expected.During evaluation of the treatment tip, service found damage to the tip membrane.Based on the available information, dielectric breakdown of the tip most likely contributed to this event.No corrective action is necessary at this time.

• 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: 17682334
• MDR Text Key: 322620358
• Report Number: 3011423170-2023-00078
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TT4.00F6-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2023
• 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