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

Model Number TTNS3.00E4-1200

Device Problems Pitted (1460); Sparking (2595)

Patient Problem Skin Discoloration (2074)

Event Date 03/07/2022

Event Type  malfunction  

Manufacturer Narrative

Evaluation of system logs has been completed and the review does not indicate there is any handpiece or system issue present.The user facility returned the treatment tip for further investigation.The tip passed flow and thermistor testing however it had failed the leak test and visual inspection.It was observed there was a burnt trace and dielectric breakdown on the tip.No further functional testing could be performed on the tip in this condition.A plant evaluation is underway.

Event Description

A user facility reported that a spark was observed from the thermage treatment tip during a patient procedure.The spark occurred after 1000 pulses.The highest treatment level used on the patient was 4.The user facility used solta medical branded cryogen and an average amount of coupling fluid.This was the first time the treatment tip had been activated and it was inspected prior to patient contact and an unknown amount of times during the procedure.No discrepancies were found.No other errors occurred with the system during operation.The patient¿s skin appeared to be burned with pinkish color and no skin breakdown on the right side of the face and neck area.No other treatments were performed in the same symptom area that day.Following the incident, the patient was recommended to use cerave healing ointment topical, sunblock and hydrocortisone.Their current status is reported as no blisters or skin breakdown and the possibility of scarring is unlikely.This is not considered a serious event, this case is being reported due to a spark occurring during the procedure.

Manufacturer Narrative

The data logs showed errors had occurred during treatment.Error indicates a recoverable problem that requires operator intervention.If the error occurs during a radio-frequency (rf) treatment, the rf 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 data the system and handpiece performed as expected.Breakdown of the dielectric material on the tip membrane can cause the rf 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.Damage to the rf trace can also cause the reported sparking noticed during treatment.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 the thermage cpt system technical user¿s manual, burns 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.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 for the serial/lot number.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 on the tip membrane.There is currently a corrective action in place for this issue.

• 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; suite 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 14002528
• MDR Text Key: 292806997
• Report Number: 3011423170-2022-00035
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

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
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 03/07/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• 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