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

Model Number	TTNS3.00E4-1200
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Conjunctivitis (1784); Eye Pain (4467); Eye Irritation (4803)
Date of Event	12/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported that they experienced conjunctival congestion and conjunctivitis to the right eye after a thermage cpt face and neck procedure.The report noted that a day after the procedure, the patient went to an ophthalmic hospital for treatment.The patient was diagnosed with conjunctival congestion and conjunctivitis and received an eye rinse and was prescribed unknown eye drops.The report noted that over two days, the symptoms have slightly improved after using the eye drops.The patient stated that during the treatment of the eye area, no protective measures were provided (no eye shields were used), and the treatment was not carried out according to the official method but with a sliding method.The patient also noted that during the procedure, the gel (likely coupling fluid) got into their eyes.After the treatment, the patient's eyes felt stinging, sore and swollen.The user facility was contacted and stated that the treatment was performed with no complication.During the facial assessment, the patient expressed a desire to retain her lower eyelid bags (under-eye hollowness) but was assured that the treatment would not be performed in that area.The facial treatment tips would only touch the outer part of the eye socket and the area around the lower eyelid.Patient's thermal feedback and skin reactions were normal throughout the process.During the treatment, the patient did not report any eye discomfort but noted eye discomfort during the cleaning.The nurse rinsed the eyes with saline, and the patient left the clinic.They contacted the site to express their concern and was reassured that there was no safety risk.The patient was offered to come to the clinic the next day for a check-up and another rinse to see if the discomfort could be relieved.However, the patient did not report to the clinic the next day and went to the hospital for a check-up.The diagnosis showed conjunctival congestion and a visible eyelash in the conjunctival sac.It is reported that based on the clinical information currently collected, the customer experienced temporary eye discomfort caused by gel (likely coupling fluid) entering the eyes.The condition has since improved, and no damage has been detected.No treatment was reported by the user facility.No picture is available.The right side of the face was treated first, with energy settings of 2.5 for the lower jaw area and 3.0-5.0 for the midface.The overall operation involved half of the reps being evenly distributed and the other half using the director's unique pushing and pinching technique, which would slightly squeeze in the direction of lifting.The energy for the periorbital area was reduced to 3.0, with approximately 30 reps allocated.The right side of the face was completed with about 450 reps, and the customer's thermal feedback and skin reactions were normal throughout the process.The left side was treated in the same way until the treatment was finished.After all the shots were completed, the director confirmed that there were no abnormalities.The current status is reported as the patient being in good condition with no permanent damage.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
A request for the treatment tip was made and the tip was not available for return and thus could not be evaluated.Datacard logs were returned and showed the following errors occurred during treatment: tip lifted/tilted during radiofrequency (rf) on, underforce during rf on, underforce during post cool, underforce during rewarm, temperature limit exceeded, and force too high when button pushed.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should the system be outside of acceptable limits.The review of the system/data logs does not indicate there is any handpiece or system issue present.When the system detects a condition that interrupts treatment, a system error code is displayed.These system error codes provide an error code number and instructions for how to respond to the error.In the event of a system error, customers need to intervene to proceed.Errors found during this treatment were possibly technique related.It is important the user maintain constant force until the tone ends (until the end of post cool state).Based on the evaluation of the data, the handpiece and system performed as expected.According to thermage cpt risk assessment, eye irritation is a known possible event during thermage cpt treatment.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 were considered acceptable, with the product performing within anticipated rates.This event is most likely unrelated to the thermage cpt treatment.Complaint data shows this is an isolated event and no other reports of conjunctivitis have been reported for thermage cpt.Based on the available information, no causal factors can be determined, and no conclusions can be drawn.At this time, no capa is necessary.

• 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: 21225772
• Report Number: 3011423170-2025-00246
• Device Sequence Number: 15527094
• Product Code: GEI
• UDI-Device Identifier: 00850608002421
• UDI-Public: 00850608002421
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Consumer,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/25/2024

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: TTNS3.00E4-1200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2024
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• 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: Female