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

Model Number	TT0.25F6-450
Medical Device Problem Codes	Degraded (1153); Device Emits Odor (1425)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Burning Sensation (2146); Blister (4537)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The treatment tip and the datalogs have been requested to be returned for evaluation.The investigation is underway.
Event or Problem Description
A user facility reported burns and blisters of the upper left eyelid following a thermage flx eye.The treating physician also observed damage to the treatment tip coating, indicating suspected dielectric breakdown.Following the procedure, the patient¿s eye area appeared pale and subsequently developed blisters.Secondary intervention was initiated by applying ice packs and a moist exposed burn ointment (mebo).The patient was instructed to continue treatment at home using mebo burn ointment and growth factor gel.As of four days post treatment, the patient was undergoing follow-up with the treating facility, and symptoms had not fully resolved; however, no permanent damage or scarring is expected.Available photographs were reviewed by the solta medical reviewer and showed mild erythema with minor blisters and associated small crusts.The medical reviewer concluded that a serious injury did not occur.However, this event meets the criteria of a reportable device malfunction due to the suspected dielectric breakdown of the treatment tip.Dielectric breakdown of the treatment tip may led to patient injury.It was reported that the patient had previously undergone regular thermage treatments for the eyes.Prior to treatment, topical lidocaine was applied to the eye area for approximately 20 minutes.An eye shield was used; however, the type of eye shield lubrication was not reported.The procedure was initiated at an energy level of 3.0 mj.After approximately 10 shots, the patient reported a burning sensation, and the energy level was reduced to 2.5 mj.A vertical lifting technique was used during the procedure.The treatment tip was inspected prior to use, and no abnormalities were noted.During the procedure, the treatment tip was inspected approximately three times.After approximately 20 shots, the device displayed a malfunction message related to the treatment tip.Upon inspection, the treatment tip was found to be slightly misaligned and was repositioned, after which the system returned to normal operation.After approximately 50 shots, a burning odor was noted.The handpiece was inspected, and patchy damage to the treatment tip coating, consistent with suspected dielectric breakdown, was observed.The procedure was immediately discontinued.It was reported that approximately 60 shots were delivered with the highest energy being 3.0 mj.The user facility confirmed using solta cryogen and approximately half a bottle of unscented solta coupling fluid.The treatment tip was retained by the user facility and has been requested for return and evaluation.
Additional Manufacturer Narrative
The treatment tip was returned for evaluation.Visual inspection identified damage to the tip coating consistent with dielectric breakdown, confirming the customer¿s report of tip damage.Dielectric membrane breakdown can result in radiofrequency energy being concentrated in a localized area of the membrane rather than being uniformly distributed, which may increase the risk of thermal injury during treatment.During evaluation, the treatment tip passed leak testing and thermistor testing.A functional test was not performed, as the tip was expired at the time of evaluation.No datacard log was provided for evaluation.No nonconformities or anomalies related to this complaint were identified during review of the device history record.The lot history, trend analysis, risk analysis, and directions for use were reviewed and found acceptable, with the product performing within anticipated rates.A review of manufacturing records confirmed that all requirements were met.According to the thermage flx user manual, burns are known possible side effects of treatment.The procedure generates heat within the upper layers of the skin and may result in burns, blistering, scab formation, and, in rare cases, scarring.Application of topical steroidal or antibiotic preparations may be beneficial.In rare instances where a burn results in a scar, the scar is typically small and may respond well to laser treatment.Solta medical has confirmed that this is the only known occurrence of potential risk to patients associated with dielectric membrane breakdown of the membrane of the treatment tip during a thermage flx procedure.Based on the available information, damage to the treatment tip membrane may have contributed to the reported event.It is unknown how the damage to the treatment tip occurred.All treatment tips are visually inspected during manufacturing.No definitive root cause can be determined.At this time, no capa is necessary.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• 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: 24639069
• Report Number: 3011423170-2026-00314
• Device Sequence Number: 18694035
• Product Code: GEI
• UDI-Device Identifier: 00816995021353
• UDI-Public: 00816995021353
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K170758
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2026

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: TT0.25F6-450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/27/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/16/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• 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 Age: 44 YR
• Patient Sex: Unknown