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

Model Number TT4.00F6-900

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

The treatment tip and treatment data log were returned for evaluation.Based on the evaluation of the data, the system and hand-piece perform as expected.The evaluation of the treatment tip indicates that the tip passed both visual inspection and thermistor testing however it failed the leak test.No functional testing was possible due to the tip being expired.A review of the device history record is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A physician reported that a burn was observed on the right forehead following a thermage treatment across the face and neck.The patient was treated with percocet and xanax tablets before undergoing the procedure.Following the procedure, once the patient returned home, they observed a burn on the right forehead and subsequent scabbing has occurred.The patient was treated in office with oxygen and given triamcinolone and aquaphor to apply to the affected area.The physician also noted that the patient underwent a dysport injection treatment in the same area two weeks prior to the thermage treatment.The physician indicated that they inspected the treatment tip before and during treatment with no abnormalities observed.The treatment was completed at a max power level of 3.5.The physician noted that they used ample coupling fluid throughout the treatment.During treatment there was an issue with the coolant canister not filling properly leading to a tip too warm error code.The treatment tip and canister were swapped out following the error code and the treatment was completed with no additional issues.

Manufacturer Narrative

Correction to h4 a review of the manufacturing records showed all requirements were met.The treatment tip and datacard log were returned for evaluation.Evaluation of the treatment tip found no issues related to the event.Based on the evaluation of the data, the system and handpiece performed as expected.Service found errors were most likely technique related.Tip too warm error places the system into a safe state and presents no patent risk.Based on the available information, burns are a known possible side effects during thermage flx treatment.

• 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: 9652617
• MDR Text Key: 185891152
• Report Number: 3011423170-2020-00016
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/02/2020

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: TT4.00F6-900
• Device Catalogue Number: TT4.00F6-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 05/19/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention