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 Codes	Blister (4537); Hyperpigmentation (4837)
Date of Event	06/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned treatment tip was evaluated and passed flow test, leak test, thermistor testing, and visual inspection.No dents, scratches, blemishes, or dielectric breakdown were observed.Functional testing was unable to be performed as there were no shots remaining.As no dielectric breakdown was observed, this event no longer meets the definition of a reportable malfunction per solta procedure.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.The datalog review did not show any handpiece or system problem.Review of manufacturing records showed that all requirements were met.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, blisters and scabbing are known possible adverse patient reactions.Provider reported that there will be no permanent damage or scarring related to this event.A medical review of this event found that the injury was not serious.This event does not meet the criteria of a reportable serious injury.No corrective action is necessary at this time.
Event or Problem Description
Upon evaluation of the device, no dielectric breakdown was observed.This event no longer meets the definition of a reportable malfunction per solta procedure.
Additional Manufacturer Narrative
The treatment tip has recently been returned, but has not yet been evaluated.The system datalogs have been reviewed.Based on the evaluation of the data, the handpiece and system performed as expected.No error codes were posted during the treatment.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, icepick-sized brown shallow scabs of the right cheek two days after the treatment.No system errors and nothing else out of the ordinary was observed during treatment.The highest energy level used was 3.5.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 current status is unknown.No permanent damage or scarring is expected.One available picture was reviewed by the solta medical reviewer.Small post inflammatory hyperpigmented lesions are visible on an unknown area, probably the cheek as noted in the case description.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.

• 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: 19802536
• Report Number: 3011423170-2024-00195
• Device Sequence Number: 15550819
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/20/2024
• 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: Unknown