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

Model Number	TTNS0.25NB1-450
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The data log from the event was requested to be returned for evaluation.The data log showed two tips were used during the treatment.With use of the first tip several errors occurred including: 109-radio-frequency (rf) delivery efficiency error, 112 - rf delivery efficiency error, 128 - overforce during rf on, 131 - underforce during rf on, 133 - underforce during rewarm, 134 - handpiece (hp) button released during pre-cool, 135 - hp button released during rf, 136 - hp button released during post-cool, 159 - tip temp is too cold, 165 - underforce during pre cool, 316 - true pwr excursion, and 317 - current excursion.With use of the second tip several errors occurred including; 133 - underforce during rewarm, 135 - hp button released during rf, 136 - hp button released during post-cool, 165 - underforce during pre cool, 316 - true pwr excursion, and 317 - current excursion.Based on available information the system did not function as expected.It's recommended the system be returned for evaluation.Two treatment tips were evaluated, and no problems were found with either tip.Both tips passed leak, thermistor, and flow testing and visual inspection.No dents, scratches, blemishes or dielectric breakdown was observed.Functional testing was not performed on either tip because there were zero treatment pulses remaining.The investigation is ongoing.
Event or Problem Description
A user facility reported that a patient experienced a second-degree burn involving the upper and lower eyelids following a thermage cpt eye procedure.A superficial anesthetic cream, sincaine 5%, was applied prior to the beginning of the treatment, however the patient reportedly was alert and able to provide feedback during the procedure.Eye shields were placed in both eyes, and the patient was given anesthetic eye drops.During treatment at approximately 100-125 pulses, the provider observed the patient¿s skin was very red but the patient advised them their skin turns red easily.The patient received topical ointment, hyperbaric oxygen therapy, and picosecond laser treatment for the injury.Additionally, the patient applied silverzine cream and ice at home.The patient¿s status is the blister had ruptured, however, it is unknown if there will be any permanent damage or scarring.The provider stated the case had been handed over to their insurance company and they do not wish to comment any further on the patient¿s recovery status.No other treatments were performed in the same symptom area on the procedure date or within 90 days prior.The patient had received an unknown aesthetic treatment in the same symptom area in the previous year.A solta medical reviewer examined images of the patient, and the images showed evidence of erythema, inflammation, and large blisters involving both the upper and lower eyelids bilaterally.Solta medical branded cryogen and 1/5 bottle of coupling fluid was used with the highest level of treatment at 3.0.During treatment an error of e316-true power excursion occurred on the system.This was the first time the treatment tip was used on a patient, and it was inspected prior to use and at every 10 pulses through the procedure, with no discrepancies observed.
Additional Manufacturer Narrative
Correction: d1.Brand name changed to "thermage cpt system tip", d4.Model # changed to "ttns0.25nb1-450, d4.Serial # changed to (b)(6).D4.Unique identifier (udi) changed to (b)(4).D9.Device available for evaluation changed to "yes." h3.Device evaluated by manufacturer changed to "yes." h5.Labeled for single use? changed to yes.H8.Usage of device changed to "initial." section d of the mdr form was subsequently updated to reflect the treatment tip as no issues were found related to the system.Although no issues were observed after a visual and functional evaluation of the treatment tip, the treatment tip is the standard device against which reporting is performed.The system was evaluated by service and no error messages were displayed during the radio-frequency (rf) treatment output test.No device issues related to this event were found during testing.Unknown what caused the reported error as the system performed within specifications.Error indicates a recoverable problem that requires operator intervention.If the error occurs during a rf treatment, the rf 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.Based on the evaluation of the data, it was reported the system may have not perform as expected.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.According to thermage cpt system technical user¿s manual, burns, blisters, and redness are known possible patient reactions 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 available information, this event is a known potential reaction to treatment.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: 23157660
• Report Number: 3011423170-2025-00300
• Device Sequence Number: 11185053
• Product Code: GEI
• UDI-Device Identifier: 00850608002278
• UDI-Public: 00850608002278
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: TTNS0.25NB1-450
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SINCAINE 5%.
• Patient Sex: Female