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

Event Date 05/04/2022

Event Type  malfunction  

Event Description

A user facility reported to a distributor that a thermage tip had sparked during a treatment and caused a burn on the right side of the patient's forehead.The patient's forehead was treated at a lower level of 2.5 and at approximately 1000 pulses the doctor noticed a spark at the edge of the tip.The treatment was stopped and the doctor tried 3 pulses on their hand, and still noticed sparks.They then inspected the tip and noted there a broken edge on the tip.Solta medical branded cryogen and a sufficient amount of coupling fluid was used with the highest level of treatment at 4.0.The tip was inspected prior to procedure and every 100 pulses until the spark occurred with no issues noted.Several event codes had also occurred on the system at this time.The tip was then replaced with a new one with no further issues for the remainder of the treatment.A medical review was performed and it was determined that no serious injury had occurred.

Manufacturer Narrative

The datalog from the patient event was reviewed and based on available information the handpiece and system performed as expected however the treatment tip did not.There were several event codes recorded prior to the customer switching to the second treatment tip.The treatment tip has been requested to be returned for further investigation and a plant evaluation is underway.

Manufacturer Narrative

The datalog and treatment tip from the patient event were returned and evaluated.Errors had occurred during treatment in the log.Errors indicate 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 an event code and message will be displayed.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.The treatment tip passed flow and thermistor testing but had failed leak testing and visual inspection.Images of the tip confirmed damage to the tip membrane along the rf trace.Breakdown of the dielectric material 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.Defects on the tip membrane can lead to a raise in temperature of the tip during treatment and can potentially cause patient burns.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.Investigation found stress concentrations on the flex assembly at the adhesive edge that damaged the rf trace, causes arcing and subsequent burn-through of the flex circuit membrane.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.Based on the available information, this event was most likely caused by damage on the tip membrane.

• 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: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122
• MDR Report Key: 14749226
• MDR Text Key: 301252257
• Report Number: 3011423170-2022-00081
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• 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
• Patient Sex: Female