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

Model Number TTNS3.00E4-1200

Device Problem Material Deformation (2976)

Patient Problems Erythema (1840); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 10/12/2022

Event Type  malfunction  

Event Description

A user facility reported that after a thermage cpt treatment, blisters appeared on the patient's face.The patient's current status is that the blisters are healing, and scabbing is reducing.The medical reviewer has deemed this as not serious.The treatment tip was returned to solta for an evaluation and dielectric breakdown was observed.

Manufacturer Narrative

The datacard logs, handpiece, and treatment tip were evaluated.The datacard log found that errors occurred during treatment.The error indicates a recoverable problem that requires operator intervention.If the error occurs during an 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.Based on the evaluation of the data, the handpiece did not perform as expected.Service evaluated the handpiece and duplicated the errors.Inspection found that the cryogen tube was short to the point of partially impeding the movement of the carriage.This can lead to the errors.Service replaced the force sensor and springs and the cable assembly.These errors do not present risk to the patient since radiofrequency delivery will be stopped.The treatment tip was evaluated and passed the flow test, leak test, and thermistor test.The tip failed the visual inspection as dielectric breakdown was observed.No functional testing was performed due to the dielectric breakdown.Breakdown of the membrane 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.Both the thermage user manual and the technical bulletin tb-19, 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.With respect to the cpt system, solta recommends that a tip membrane inspection be performed at the outset of the procedure and every 50 (fifty) pulses thereafter.According to the thermage cpt system technical user¿s manual burns, blisters, scabbing, and scarring are known possible patient reactions to the thermage treatment.The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.A review of the manufacturing records showed all requirements were met.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, this event was most likely caused by damage to the tip.No corrective action is required.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Type of Device: 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: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 15763878
• MDR Text Key: 307731635
• Report Number: 3011423170-2022-00142
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1