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

Model Number TTNS3.00E4-1200

Device Problems Material Discolored (1170); Dent in Material (2526)

Patient Problems Erythema (1840); Blister (4537)

Event Date 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

Datalogs were reviewed and based on the evaluation of the data, the handpiece and system performed as expected.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should the system be outside of the acceptable limits.The review of the system/data logs does not indicate there is any handpiece or system issue present.Errors indicate a recoverable problem that requires operator intervention.If the error occurs during a radiofrequency treatment, the radiofrequency 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.The tip was evaluated by service and confirmed burn marks and a dent on the tip surface.The tip passed the flow, leak, and thermistor tests.The tip failed visual inspection due to the dent and burn marks on the tip surface, as dielectric breakdown was observed.The tip also failed functional testing.The dent in the tip would not cause this event, but dielectric membrane breakdown of the dielectric material can cause the radiofrequency energy, delivered by the system, to focus in a small area of the membrane, rather than to be uniformly distributed over the entire membrane area.Dielectric membrane breakdown on the tip membrane can lead to a rise in temperature of the tip during treatment and can potentially cause patient burns.Thermage cpt system technical user¿s manual instructs the operator to inspect the treatment tips for any signs of physical damage prior, during, and after treatment.With respect to all thermage systems, clinicians should frequently inspect the tip membrane during treatment for signs of breakdown and build-up of foreign substances.According to thermage cpt system technical user¿s manual, blisters are known possible reactions 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/or directions for use review were considered acceptable, with the product performing within anticipated rates.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.It is undetermined when and how the dent happened as all tips are visually inspected during the manufacturing and packaging process for any signs of damage to the tip membrane.Based on the available information, dielectric membrane breakdown to the tip caused this event.No corrective action is required.

Event Description

A user facility reported a slight depression on the film on the front of the treatment tip.When the operation reached about 300 reps, the physician observed slight redness of the customer's skin fading and accompanied by the appearance of blisters.The physician immediately stopped the treatment and promptly treated the area on the patient.The next day after the treatment, multiple blisters were visible.Since then, the patient has recovered.Information was reviewed by the medical reviewer who deemed this case as not serious.The thermage treatment tip was sent in for an evaluation where dielectric breakdown was observed.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 16154151
• MDR Text Key: 308172346
• Report Number: 3011423170-2023-00005
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1