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

Model Number TTNS3.00E4-900

Device Problems Sparking (2595); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device has been requested for return and evaluation, but has not yet been received.A review of the device history record is in progress.Based on available information, no causal factors can be determined and no conclusion can be drawn at the time of this report.

Event Description

A physician reported traces of sparks during a thermage treatment.The physician inspected the tip and found damage to the tip membrane.The tip was replaced and treatment continued.There was no patient injury.

Manufacturer Narrative

It was reported there were traces of sparks coming from a thermage tip during treatment.No system errors were reported during the treatment.The doctor inspected the tip membrane and discovered damage and replaced it to continue treatment.No patient injury occurred.Defects on the tip membrane can lead to a rise in temperature of the tip during treatment and can potentially cause patient burns.Investigations have found glowing or sparking from the tip membrane are caused by stress concentrations on the flex assembly at the adhesive edge that damaged the radio frequency trace, causing arcing and subsequent burn-through of the flex circuit membrane.No tip returned for evaluation so customer¿s complaint could not be confirmed.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• MDR Report Key: 11282022
• MDR Text Key: 231369129
• Report Number: 3011423170-2021-00016
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-900
• Device Catalogue Number: TTNS3.00E4-900
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1