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

Model Number	TTNS3.00E4-900
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); Blister (4537); Hyperpigmentation (4837)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient experienced blisters and secondary thermal burns following a thermage cpt treatment.Solta medical branded cryogen and approximately one bottle of coupling fluid was used with the highest level of treatment at 1.5.The patient received treatment on their face and neck.Around 600 pulses, the system gave a warning the maximum tip temperature had been reached.The treatment tip was inspected prior to use, and during the treatment, however it's unknown how frequently it was checked during use.After the treatment in the evening, the patient reportedly observed blisters a secondary thermal burn on the left side of their neck.The patient was prescribed steroids with antibiotics as a results of this event.No other procedures were performed in the same symptom area on the day of the procedure.It is unknown if the patient received any other procedures or aesthetic treatments within 90 days of this treatment or anytime in their past history in the same symptom area.The patient's current outcome is unknown at this time.A solta medical reviewer examined photos of the patient injury.Post inflammatory hyperpigmentation was visible mostly on one side of the neck.This event meets reportability requirements as the medical reviewer has deemed it a serious injury.
Additional Manufacturer Narrative
The data logs and treatment tip have been requested to be returned for evaluation but have not yet arrived.The investigation is ongoing.
Additional Manufacturer Narrative
The data logs from the event were reviewed.There were many instances of temperature related errors indicating the tip had exceeded its programmed temperature limit.Based on evaluation of the data, the system performed as expected.The tip has been requested but has not yet been returned for evaluation.
Additional Manufacturer Narrative
The data logs from the event were reviewed.The data card log confirmed customers report of over temperature error (e138).It is unknown what caused this error during treatment.These error codes could have been caused by customer techniques during treatment.Failure to maintain constant force or contact until the tone ends (until the end of post cool state) can result in an unsafe condition.Error indicates a recoverable problem that requires operator intervention.If the error occurs during a radio-frequency treatment, the radio-frequency 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 data card log, the handpiece potentially did not perform as expected.Service could not confirm issues with the handpiece since customer declined to return the handpiece for evaluation since the handpiece was being used on the system and no errors were occurring.The treatment tip was evaluated and passed flow, leak, and thermistor testing, however failed visual inspection.A dent was observed on the tip membrane.It is unknown what caused the dent.A dent on the tip membrane does not cause risk to patient since radio-frequency energy is able to distribute evenly across the tip membrane.No dielectric breakdown was observed.Functional testing could not be performed due to all reps being used.According to thermage cpt system technical user¿s manual burns and blisters are a known potential reaction to 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.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.Based on the available information, no causal factors can be determined, and no conclusions can be found.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 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC.; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 18499380
• Report Number: 3011423170-2024-00114
• Device Sequence Number: 8088198
• Product Code: GEI
• UDI-Device Identifier: 00850608002445
• UDI-Public: 00850608002445
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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,Followup
• Report Date (Section B): 12/14/2023

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: TTNS3.00E4-900
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/20/2024; 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2023
• 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