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

Model Number TTNS3.00E4-1200

Device Problem Sparking (2595)

Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

The product was returned and evaluated.Tip passed the functional testing and no sparks were observed.The tip passed the flow test, leak test, and thermistor testing.The visual inspection failed as dielectric breakdown was observed.Log files were observed and based on the evaluation of the data, the handpiece and system performed as expected.Errors seemed to have occurred due to improper hand technique.This investigation is ongoing.

Event Description

The user facility reported that they were performing a face treatment and saw a spark from the treatment tip.She noticed the patient had petechia with small red dots on her right cheek.This event occurred at about 300 pulses with an energy level of 3.0.She changed the treatment tip and continued the treatment with a different tip and had no further issues.Patient was given medical barrier cream by epionce.

Manufacturer Narrative

A medical review of this case determined this event was not a serious injury.Based on the evaluation of the data, the handpiece and system performed as expected.Evaluation of the treatment tip confirmed damage along the rf trace of the tip.Investigation found damage to the rf trace are caused by stress concentrations on the flex assembly at the adhesive edge that damage the rf trace, causing arcing and subsequent burn-through of the flex circuit membrane.Based on the available information, this event was most likely caused by damage on the treatment tip.It was reported no permanent damage or scarring would occur because of this event.Errors seemed to have occurred due to improper hand technique.A review of the manufacturing records showed all requirements were met.Defects on 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 and can potentially cause patient burns.This can also cause sparking from the tip during treatment confirming customers report of sparking during treatment.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record for serial/lot number (b)(6).

• 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; bothel WA 98011
• MDR Report Key: 11177906
• MDR Text Key: 228182339
• Report Number: 3011423170-2021-00007
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1