MAUDE Adverse Event Report: SOLTA MEDICAL INC. THERMAGE CPT SYSTEM; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number TTNS3.00C1-400

Device Problems Temperature Problem (3022); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Itching Sensation (1943); Burning Sensation (2146)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

The treatment tip has been discarded and is not available for evaluation.Data log of the treatment was received and reviewed.The system logs showed the system might not have performed as expected.All thermistors values from tm1 to tm4 appeared on the colder side meaning the system read the total tip thermistors¿ resistance were high (almost open).This issue caused multiple error codes.Based on available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A patient reported they experienced a burn on their neck and lower lateral part of their face following a thermage treatment.The patient reported at first feeling an itching sensation and then a physical burn was observed.Upon follow-up with the treating clinic, they reported the procedure was completed at a maximum power of only 1.5 and ample coupling fluid was used.The treatment tip was not inspected prior to or during the treatment.It was noted that error codes were displayed during the treatment.The patient did have a glycolic peel and facial 20 days prior to treatment.The patient was prescribed prednisolone and fucibet cream was applied for treatment once.Available patient images were reviewed and areas of redness and inflammation are visible on the neck and lower lateral part of the face.The patient outcome is noted as probable post inflammatory pigmentation.

Manufacturer Narrative

According to thermage cpt system technical user¿s manual (p009240-05 rev.B) burns are a known possible patient reaction to thermage treatment.The procedure may produce heating in the upper layers of the skin, causing 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.Based on the evaluation of the data, the system did not perform as expected.All thermistors values from tm1 to tm4 appeared on the colder side meaning the system read the tip thermistors¿ resistance were high.After repair, system is working within specifications.Issues related to the hand-piece interface board caused errors "tip is too cold" and "tip lifted" and stopped the radio-frequency treatment tip in order to prevent any harm to the patient.When an error occurs it indicates a recoverable problem that requires operator intervention.If the error occurs during an radio-frequency treatment, the radio-frequency delivery will be stopped, then a post-cooling step will be completed prior to generating an ¿error tone¿ and displaying the event code and event message.After the error tone, the system will transition into action required mode and will display text with instructions for the operator indicating what action may be required to resolve the issue a review of the manufacturing records showed all requirements were met.The data-card logs were returned for evaluation.No tip was returned for evaluation.Based on the evaluation of the data, the system did not perform as expected causing errors during treatment.Radio-frequency treatment was stopped during the errors, preventing any harm to the patient at those times.Based on available information, no causal factors can be determined, and no conclusions can be drawn.

• Brand Name: THERMAGE CPT SYSTEM
• 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: 11030651
• MDR Text Key: 222285059
• Report Number: 3011423170-2020-00139
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00C1-400
• Device Catalogue Number: TTNS3.00C1-400
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention