MAUDE Adverse Event Report: SOLTA MEDICAL, INC. THERMAGE CPT SYSTEM AND ACCESSORIES; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI

Model Number	TTNS3.00E4-1200
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Blister (4537)
Date of Event	05/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the datalog showed that the system and handpiece performed as expected.System errors were identified showing that the treatment tip was lifted or tilted while radiofrequency was on, the handpiece button was released during radiofrequency, and there was insufficient force during radiofrequency.Functional testing of the thermage system radiofrequency energy showed it operated within optimal specification and passed all tests.Evaluation of the treatment tip identified dielectric breakdown.The investigation is underway.
Event or Problem Description
A user facility reported sparks from the treatment tip during a thermage cpt treatment of the face, neck, and eyes.The patient experienced blisters and reported small, one-third penny- sized and icepick-sized brown shallow scabs of the right and left cheek two days after the treatment.The patient was treated with a sliding method.No system errors and nothing else out of the ordinary was observed during treatment.The highest energy level used was 5.5.Solta cryogen and two bottles of coupling fluid were used during the treatment.The treatment tip was inspected prior to use and every ten reps, with no anomalies noted.This was the initial use of the treatment tip.No other treatments were being performed in the affected area at the time of the thermage cpt treatment and the patient had no history of aesthetic treatments of the area.No secondary intervention was used for the affected areas, as the patient did not have any symptoms the day of the treatment.The patient¿s blisters have peeled off with red stains remaining.No permanent damage or scarring is expected.Available pictures were reviewed by the solta medical reviewer.Small scabs are visible on one side of the patient's cheek.Two other pictures from the other side of patient cheek shows a small wound.Time of pictures was not specified.This event was deemed not serious by the medical reviewer.This event does not meet reportability requirements as a serious injury.Sparking is a reportable malfunction per solta procedure.Thus, this event meets reportability requirements as a reportable malfunction.
Additional Manufacturer Narrative
The device was not returned for evaluation.The evaluation for a different tip was inadvertently documented in the evaluation for this case.The treatment tip was not evaluated.No tip evaluation was performed for tip related to this event, as the tip was not available for evaluation.Evaluation of the data log found that the following errors occurred during treatment: quantity - error id - description - percent of reps 13 - 131 - underforce during rf on - 1.08%.1 - 135 - hp button released during rf - 0.08%.11 - 76 - tip lifted/tilted during rf on - 0.92%.An error indicates a recoverable problem that requires operator intervention.If the error occurs during a radiofrequency (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 display text with instructions for the operator indicating what action may be required to resolve the issue.Based on the evaluation of the data log, the system and handpiece performed as expected.Final test verification specifications are acceptable.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.According to the thermage cpt user manual, blisters and scabbing are known possible adverse patient reactions to thermage cpt 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.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, no causal factors can be determined, and no conclusions can be drawn.The provider reported that there will be no permanent damage or scarring related to this event.No corrective action is necessary at this time.

• Brand Name: THERMAGE CPT SYSTEM AND ACCESSORIES
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORI
• 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: 19796201
• Report Number: 3011423170-2024-00194
• Device Sequence Number: 7096914
• Product Code: GEI
• UDI-Device Identifier: 00850608002421
• UDI-Public: 00850608002421
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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
• Device Model Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2019
• 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