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

Model Number	TTNS0.25NB1-450
Medical Device Problem Codes	Sparking (2595); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The thermage cpt tip was evaluated by service.The treatment tip passed the flow and the thermistor test; however, the tip failed the leak test and the visual inspection as dielectric breakdown was observed.The maximum temperature reached event code was not confirmed as functional testing could not be performed due to visible dielectric breakdown on the tip membrane.Observation of dielectric breakdown upon tip evaluation meets the definition of a reportable malfunction per solta procedure due to the propensity of tips with dielectric breakdown to cause or contribute to patient injury.Solta medical has confirmed a low incidence (less than 1% of the total estimated number of treatments) of first- and second-degree patient burns associated with dielectric membrane breakdown of the membrane of the treatment tip which contacts the patient during a thermage cpt procedure.Breakdown of the 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.In addition to recommending frequent tip membrane inspection, solta emphasizes its recommendation to carefully monitor the condition of the patient¿s skin during treatment.Both the thermage user manual and the technical bulletin instructs the operator to inspect the treatment tips for any signs of physical damage prior, during, and after a treatment.With respect to all thermage systems clinicians should frequently inspect the tip membrane during treatment for signs of breakdown and build-up of foreign substances.With respect to the cpt system, solta recommends that a tip membrane inspection be performed at the outset of the procedure and every 50 (fifty) pulses thereafter.A review of manufacturing records showed that all requirements were met.No nonconformities or anomalies were found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Defects on the tip membrane can lead to a raise in temperature of the tip during treatment and can potentially cause patient burns.It is unknown how this damage occurred as all treatment tips are visually inspected during manufacturing.At this time, no capa is necessary.
Event or Problem Description
The user facility reported a maximum temperature reached event code and a flashing light that appeared at the end of the treatment tip after starting a thermage cpt treatment.There was no injury to the patient, the procedure was resumed after removing the affected treatment tip and placing a new one.The treatment tip was returned to solta for an evaluation and dielectric breakdown was observed; therefore, this meets the reportability requirements for a malfunction.
Additional Manufacturer Narrative
A review of the uploaded datalog was performed.It was determined that during treatment, the system appropriately detected a dielectric breakdown condition and responded by immediately terminating radiofrequency energy delivery and displaying a true power excursion error code.A temperature limit exceeded error code was also recorded once, which may have occurred as a result of the dielectric breakdown condition and/or handpiece positioning at that time.These responses demonstrate proper system safety functionality.Based on the evaluation, the system and handpiece performed as expected, while the treatment tip did not perform as intended.The conclusions from the previous report submission remain unchanged.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Common Device Name: 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 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 north creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 22654515
• Report Number: 3011423170-2025-00289
• Device Sequence Number: 21032270
• Product Code: GEI
• UDI-Device Identifier: 00850608002278
• UDI-Public: 00850608002278
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TTNS0.25NB1-450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown