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 Bruise/Contusion (1754); Erythema (1840); Inflammation (1932)

Event Date 12/05/2020

Event Type  malfunction  

Manufacturer Narrative

The tip was returned and evaluated.The evaluation revealed that the tip passed flow, leak and thermistor testing.It failed visual testing due to the observation of dielectric breakdown on the tip.No functional testing was performed due to the existence of dielectric breakdown.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 clinic reported that while performing a thermage treatment, they observed a small spark at 100 pulses.Since the initial spark was so small the esthetician was not sure if it was actually a spark and continued with the treatment.At 700 pulses, a second and bigger spark was observed and the treatment was stopped.The tip was inspected prior to treatment and after the first spark, no visible damage was observed.The highest energy used was 2.5 and an ample amount of coupling fluid was used.No system errors were reported during the procedure.The patients experienced capillary damage from the spark and bruising may follow, however there was no serious injury to the patient.

Manufacturer Narrative

Service evaluation of the treatment tip confirmed damage along the radio frequency trace of the tip.This evaluation confirms the customer¿s account of possible sparking from the tip membrane during treatment.Defects on the tip membrane can lead to a raise in temperature of the tip during treatment and can potentially cause patient burns or other events.The datacard was not evaluated so it is unclear if any errors occurred that alerted operator.A review of the manufacturing records showed all requirements were met.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.This event was mostly caused by the damage to the tip.It is uncertain where damage to treatment tip occurred, treatment tips are inspected during manufacturing for any defects.

• 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: 11120566
• MDR Text Key: 229337659
• Report Number: 3011423170-2021-00002
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

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: No Information
• 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: 12/08/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1