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

Model Number TTNS3.00E4-1200

Device Problems Dent in Material (2526); Material Deformation (2976)

Patient Problems Burn(s) (1757); Erythema (1840); Skin Inflammation/ Irritation (4545)

Event Date 10/21/2023

Event Type  malfunction  

Manufacturer Narrative

The data log from the event was evaluated and showed some force-related errors and activation button release errors had occurred.Errors indicate a recoverable problem that require 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.The treatment tip was returned and evaluated.The tip passed flow, leak, and thermistor testing however failed visual inspection.There was a dent found in the middle of the membrane and damage in the corner, where dielectric breakdown was observed.Further functional testing could not be performed as the tip was already expired when received.A dent to the tip would not cause risk to patient.Dielectric breakdown of the membrane can cause the radio-frequency 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 possibility causing patient burns.According to thermage cpt system technical user¿s manual, burns are a known possible patient reaction to thermage 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 non-conformities or anomalies found related to this complaint when reviewing the device history record for the serial number.Based on the available information, dielectric breakdown of the tip most likely contributed to this event.No corrective action is necessary at this time.

Event Description

A user facility reported that a patient experienced a burn following a thermage cpt treatment.Solta medical branded cryogen and 1.5 bottle of coupling fluid was used with the highest level of treatment at 3.5.No system errors occurred during treatment, and the tip was inspected prior to use and at every 50 pulses with no discrepancies found.After the treatment was completed, a dent was observed in the tip membrane.After the burn was discovered, the patient was prescribed polysporin two times a day.The patient had not received any other treatment in the symptom area on the procedure day or within 90 days prior.The patient¿s outcome was reported as almost recovered with no scarring expected.A solta medical reviewer examined photos of the patient injury.Erythema, inflammation and mild hyperpigmented lines were visible on the cheek area.The medical reviewer determined this was not a serious injury.As such, the event did not initially meet reportability requirements.The treatment tip was returned to solta depot where it was observed dielectric breakdown was visible on the tip membrane.This event meets reportability requirements as it is a reportable malfunction per solta procedure.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC; 11720 north 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: 18499303
• MDR Text Key: 332740649
• Report Number: 3011423170-2024-00115
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K173759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2023
• 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