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

Model Number TTNS3.00E4-1200

Device Problems Pitted (1460); Sparking (2595)

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

Event Type  malfunction  

Manufacturer Narrative

The tip was returned and evaluated.The evaluation revealed that the tip passed leak, flow, and thermistor testing.It failed for visual inspection due to the observance of a broken membrane and dielectric breakdown on the tip.No functional testing could be performed due to dielectric breakdown being observed.A review of the device history records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A physician reported that a spark occurred at 834 reps during a thermage treatment.No patient injury was reported.

Manufacturer Narrative

During evaluation of the treatment tip, service confirmed damage of along the radio frequency trace of the tip.This evaluation confirms customer¿s account of damage to the tip membrane during treatment.Defects on the tip membrane can lead to a rise in temperature of the tip and can potentially cause patient burns during treatment.The datacard was not evaluated so it is unclear if any errors occurred that alerted operator.A review of the manufacturing records showed that all requirements were met.No patient injury occurred during treatment.Investigation found flame/spark from tip membrane are caused by stress concentrations on the flex assembly at the adhesive edge that damaged the rf trace, causing arcing and subsequent burn-through of the flex circuit membrane.

• 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: 11322227
• MDR Text Key: 241928259
• Report Number: 3011423170-2021-00022
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 02/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1