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

Model Number TT4.00F6-600

Device Problem Temperature Problem (3022)

Patient Problem Blister (4537)

Event Date 01/17/2023

Event Type  Injury  

Manufacturer Narrative

The data logs from the event were reviewed and 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.Cryogen appeared to be flowing during the treatment.The user performed one treatment in the morning and the system was turned off.Then treatment began 5 minutes later.The cryogen can pressure had not reached normal pressure and the user experienced "tip too warm errors" during initial use.The user should wait at least 10 minutes after power on before beginning treatment for the system to reach proper reservoir pressure and cryogen can pressure.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 user facility indicated the treatment tip was not available to return for evaluation.According to thermage flx user manual, blisters are a 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.Final test verification specifications are acceptable.No non-conformities or anomalies were found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and/or 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 and no conclusions can be drawn.No corrective action is required.

Event Description

A user facility reported that a patient experienced blisters on the right nasolabial fold on their face the day following a thermage flx treatment.There were no other treatments performed in the same symptom area on the procedure day or within 30 days prior.The patient was treated with antibiotics and silvadene cream and their current status is reported as recovering.Solta medical branded cryogen and one half of a bottle of coupling fluid was used with the highest level of treatment at 2.5.During the treatment a ¿tip too warm¿ error occurred on the system which paused the procedure briefly, but the provider was able to continue.The treatment tip was inspected prior to use and again at 600 pulses with no discrepancies found.The tip is not available to be returned.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 16380152
• MDR Text Key: 309588202
• Report Number: 3011423170-2023-00020
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 01/18/2023

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: TT4.00F6-600
• Device Catalogue Number: TT4.00F6-600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention