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

Model Number	TT0.25F6-225
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Hyperpigmentation (4837)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the evaluation of the data, the hp and system performed as expected.The tip has been returned but has not yet been evaluated.The investigation is under way.
Event or Problem Description
It was reported that a patient experienced burns on the lower eyelid after a thermage flx eye treatment.An eye shield was used treatment during the treatment.The doctor reported having trouble with the treatment and could not progress after 23 reps due to receipt of a radiofrequency power error/tuning failure.The highest energy level used was 2.0.No additional treatments were being performed at the same time as the thermage flx treatment.Solta medical cryogen and coupling fluid (1ml) were used for the treatment.This was the initial use of the treatment tip, which was inspected prior to treatment but not throughout the treatment.No secondary intervention was necessary as a result of the burn.Two available pictures were reviewed by the solta medical reviewer.The sequence of pictures and timing are unclear; therefore, the healing process cannot be determined.One picture shows minor crusts under eyelid with erythema on the cheek, and the second picture shows a hyperpigmented line under the eyelid and minor erythema on the cheek.Though requested, no additional information has been received.The patient¿s current status is unknown and it is unknown if there will be permanent damage or scarring.
Additional Manufacturer Narrative
Evaluation of the treatment tip has been completed.The tip passed leak and thermistor testing but was not able to have functional testing completed due to the tip being expired.The tip failed visual inspection due to a sharp corner from glue.No dielectric breakdown was observed.Evaluation of treatment tip found no issues related to this event.The radiofrequency energy was able to distribute evenly across the tip membrane.Evaluation of the data found that the following errors occurred during treatment: quantity - error id - description - percent of reps.(b)(4).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.Based on the evaluation of the data, the handpiece and system performed as expected.Data log confirmed provider¿s report of ed4c2 (gen tuning failure) error.This error presents no risk to patient.A review of the manufacturing records showed all requirements were met.Final test verification specifications are acceptable.No nonconformities or anomalies found related to this event 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 flx system user manual, burns are known possible adverse patient reactions to thermage flx treatment.The procedure produces heating in the upper layers of the skin and may cause burns and subsequent blister and scab formation.There is a small chance of scar formation.Based on the available information, burns are known possible adverse patient reactions to thermage flx treatment.No corrective action is necessary at this time.
Additional Manufacturer Narrative
The conclusions of our previous submission remain unchanged.
Event or Problem Description
Additional information indicates that the patient's condition has improved and that further details are available.The event remains assessed as a serious injury per the solta medical reviewer.

• Brand Name: THERMAGE FLX (TG-3A) 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: 19660793
• Report Number: 3011423170-2024-00182
• Device Sequence Number: 17753912
• Product Code: GEI
• UDI-Device Identifier: 00816995021346
• UDI-Public: 00816995021346
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 06/03/2024

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: TT0.25F6-225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 07/17/2024; 09/07/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/15/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• 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