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

Model Number TTNS3.00E4-1200

Device Problems Arcing (2583); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2022

Event Type  malfunction  

Event Description

A distributor reported that a user facility had performed thermage treatment on a patient and the tip was damaged.The customer had smelled a burning odor during the treatment and found the tip surface was broken.The tip was replaced with another and there were no other problems for the remainder of the procedure.No patient injury had occurred.The tip was returned and evaluated where dielectric breakdown was found on the tip membrane.

Manufacturer Narrative

The data log from the patient event and treatment tip have been returned for evaluation.The data log showed error codes had occurred during the patient treatment.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 the data, the handpiece and system performed as expected.The treatment tip passed thermistor, flow and leak testing but failed visual inspection.Service confirmed damage on the tip membrane along the rf trace.Investigation has found rf trace damage on the tip membrane is caused by stress concentrations on the flex assembly at the adhesive edge that damaged the rf trace.This damage can cause arcing and subsequent burn-through of the flex circuit membrane.A review of the manufacturing records showed all requirements were met.The lot/device history review and/or trend analysis was considered acceptable and the product was 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 for the serial/lot number.The root cause was determined to be a component issue.There is currently a corrective action in place for further investigation of the 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 n; suite 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st louis, MO 63122 ; 6362263220
• MDR Report Key: 15363188
• MDR Text Key: 305622006
• Report Number: 3011423170-2022-00115
• 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
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• 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