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

Model Number	TTNS0.25NB1-450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Blister (4537); Hyperpigmentation (4837)
Date of Event	01/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient experienced burns and blisters on their eye area following a thermae cpt treatment.Solta medical branded cryogen and two bottles of coupling fluid was used with the highest level of treatment at 4.0.Prior to the procedure the patient was administered dormicum as an anesthetic.Eye shields were inserted and treatment was delivered to the patient's eye areas.No system errors occurred during the treatment.This is the first time the treatment tip has been used and it was inspected prior to treatment with no discrepancies found.The tip was not inspected again throughout the procedure.The day following the procedure the patient observed burns and blisters around one eye.The patient had not undergone any other treatments in the same symptom area on the procedure date or within 90 days prior.The patient did receive btl exilis radio-frequency treatment to the symptom area on october 7, 2023.The patient¿s current outcome is not known at this time.A solta medical reviewer examined photos of the patient injury.One picture showed crusting under the eye and hyperpigmented areas around the eye.The second picture showed an open blister under the eye and hyperpigmented areas around the eye.
Additional Manufacturer Narrative
The data log from the event was reviewed.Several force-related errors occurred during treatment.Based on available information the system and handpiece performed as expected.The treatment tip was requested to be returned for evaluation but has not yet arrived.The investigation is ongoing.
Additional Manufacturer Narrative
The data log and treatment tip from the event were returned and evaluated.The data log showed several force related errors had occurred during treatment.Errors indicate 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 evaluation of the data, the handpiece and system performed as expected.Evaluation of the treatment tip found no issues with related to this event.The tip passed flow, leak, and thermistor testing and visual inspection.No dents, scratches, blemishes or dielectric breakdown was observed.Functional testing could not be performed due to all treatments being used.Burns and blisters are known possible adverse patient reactions to thermage cpt treatment.Thermage system technical user¿s manual states 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.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 non-conformities or anomalies found related to this complaint when reviewing the device history record for the serial number.Based on the available information, this event is a known possible reaction to treatment.No corrective action is necessary at this time.
Additional Manufacturer Narrative
The event no longer meets reportability requirements.The investigation and conclusions from our initial assessment remain unchanged.
Event or Problem Description
Solta received information on the patient's current status and outcome.The patient still has some redness remaining on their lower eyelids however no permanent scarring is expected.The medical reviewer has reassessed the file and with the new information has deemed the event not serious.As such, the event no longer meets reportability requirements.

• 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: 18753922
• Report Number: 3011423170-2024-00127
• Device Sequence Number: 19768249
• Product Code: GEI
• UDI-Device Identifier: 00850608002278
• UDI-Public: 00850608002278
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2024

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: TTNS0.25NB1-450
• 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; 06/18/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/08/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DORMICUM
• Patient Sex: Unknown