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

Model Number	TTNS3.00E4-1200
Medical Device Problem Codes	Insufficient Cooling (1130); Material Puncture/Hole (1504); Material Deformation (2976)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Scar Tissue (2060); Skin Disorders (4543); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577); Hyperpigmentation (4837)
Date of Event	01/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient experienced a burn on their face following a thermage cpt treatment.During the procedure the provider delivered approximately 896 pulses when a cryogen error message was shown on the system display.The system was powered off and cryogen was reseated to clear the error, but the provider noticed there was a hole in the treatment tip and the patient had sustained a burn injury on the right side of their face, specifically on the under-eye area extending from the nose/cheek region to the ear.The provider applied ice and polysporin to the affected areas.The patient¿s current status is that there is persistent subdermal darkening and uneven skin texture following prior scarring.The provider indicated that while the condition is not severe, additional intervention is needed to support recovery.The patient did not undergo any other treatment on the procedure date.The patient did receive a hyrdofacial treatment within 90 days prior to the treatment and had received thermage treatment approximately one year prior.A solta medical reviewer examined an undated photo of the patient injury.It was observed in the photo there was diffuse erythema, inflammation, and swelling involving one cheek and the periorbital region.There was no evidence of crusting or an open wound.At the time the medical reviewer deemed the injury as not serious.An updated image was reviewed twenty-four days post-procedure which showed mild, scattered erythematous papules consistent with low-grade inflammatory changes on the right facial cheek area.There is evidence of mild post-inflammatory hyperpigmentation and residual textural irregularity consistent with prior scarring.The medical reviewer changed the injury to serious.This event meets reportability requirements as the medical reviewer has deemed it a serious injury.Solta medical cryogen and 1 ½ bottle of coupling fluid was used with the highest level of treatment at 5.0.Energy used on the cheek was at a level of 5.0 while a lower energy level of 3.0 was used below the eye area.This was the first time the treatment tip was used on a patient, and it was inspected prior to use and every 600 pulses with no discrepancies found prior to the hole in the tip membrane being discovered.The treatment tip was returned to depot for evaluation where dielectric breakdown of the tip membrane was observed.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.
Additional Manufacturer Narrative
This event meets reportability requirements as the medical reviewer has deemed it a serious injury.The data logs from the event were unavailable for evaluation.The treatment tip was returned for evaluation.The tip passed flow, leak, and thermistor testing however it failed visual inspection due to the observation of dielectric breakdown on the tip membrane.Functional testing was performed (50 treatments) with no errors or other issues observed.This event meets reportability requirements as it is a reportable malfunction per solta procedure.The investigation is ongoing.
Additional Manufacturer Narrative
Tip evaluation confirmed damage to the tip membrane along the radio-frequency (rf) trace.Breakdown of the dielectric material can cause the rf 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.Defects on the tip membrane can lead to a raise in temperature of the tip during treatment and can potentially cause patient burns.This confirms customer account of damage to the tip.The thermage cpt system technical user¿s manual instructs the operator to inspect the treatment tips for any signs of physical damage prior, during, and after 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.According to the thermage cpt system technical user¿s manual, burns, scarring, discoloration, redness, and surface irregularities are known potential reactions to 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.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Review of manufacturing records show final manufacturing test verification specifications are acceptable.No nonconformities or anomalies were found related to this event when reviewing the device history record.Based on the available information, this event was most likely caused by damage on the tip membrane.It is unknown what caused this damage.All treatment tips are visually inspected during the manufacturing process.No corrective action is necessary at this time.

• 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: 24526266
• Report Number: 3011423170-2026-00315
• Device Sequence Number: 21255649
• Product Code: GEI
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2025
• 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: Female