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

Model Number TT4.00F6-600

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Scarring (2061)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested but not received.The doctor has discarded the treatment tip.A review of the device history records is in progress.Based on available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A physician reported that they observed atrophic scarring on a patient's right upper eye brow two weeks after undergoing a full face thermage laser treatment.The physician reported that the treatment was performed at an energy level between 1.0 and 1.5.During the treatment the patient complained that the treatment was painful and the physician observed multiple tip too warm error codes.The physician reported that the surface of the tip was not cool to the touch.The physician used 30ml of cryogen and coupling fluid during the procedure, and later called to complain that they thought the cooling system may not be functioning correctly.Two weeks post treatment the patient visited the physician and at that time the physician observed an atrophic scar on the upper side of the right eyebrow.The physician reports that it is not a serious scar but it needs observation.No secondary intervention or medications were prescribed.

Manufacturer Narrative

Treatment data log was provided by the practitioner for review.Based on the evaluation of the data, the hand-piece and system performed as expected, however, the thermistors in the tip were heating unevenly.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.Evaluation found there were user technique issues and uneven treatments during reps.Thermistor temperatures were cold on one side and hot on the other during treatments.The temperatures changed as customer turned the hand-piece.According to the thermage flx user manual surface irregularities are a known possible side effects during a thermage flx treatment.Frequently, surface irregularities are not evident immediately post-treatment, but show up later (1 or more months post-treatment).In most cases solta recommends that surface irregularities be monitored for a period of six months post onset.Data-card log confirmed customer¿s account of tip too warm error and found this error most likely due to customer technique issues.This error presents no patient risk.Based on the available information, surface irregularities are a known adverse effect of the procedure.

• 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
• MDR Report Key: 9221040
• MDR Text Key: 163303003
• Report Number: 3011423170-2019-00105
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR