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

Model Number TTNS3.00E4-1200

Device Problems Dent in Material (2526); Sparking (2595); Flare or Flash (2942)

Patient Problem Burn(s) (1757)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Product evaluation showed the tip passed flow and thermistor testing.The tip failed leak testing and visual inspection.Dents and dielectric breakdown were 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.This investigation is ongoing.

Event Description

A clinic reported a spark during pulse delivery.This occurred at 420 reps at the tip on the end of the left side when it started sparkling fire.The skin was checked and appeared ok.The tip was inspected and removed.Treatment was continued on the other side of face with another tip to finish the treatment.The tip was inspected prior to use, as well as during use at about 200 reps; nothing was noted.On (b)(6) 2020, patient reported burns on her face.The patient was instructed to apply hydrocortisone as home care post treatment and to apply the ointment on the open scabs and to not remove or peel off the skin.

Manufacturer Narrative

Evaluation of the treatment tip confirmed damage along the radio frequency trace of the tip.Defects on the tip membrane can cause the radiofrequency 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 and can potentially cause patient burns.This can also cause sparking from the tip during treatment confirming customers report of sparking during treatment.Both the thermage user manual (p009240-05 rev.B) and technical bulletin tb-19 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.With respect to the cpt system, solta recommends that a tip membrane inspection be performed at the outset of the procedure and every 50 (fifty) pulses thereafter.According to thermage cpt system technical user¿s manual (p009240-05 rev.B) burns, blisters, scabbing, are a known possible patient reaction to thermage treatment.The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.There is a small chance of scar formation.Application of topical steroidal or antibiotic preparations may be of benefit.In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record for serial/lot number (b)(6).A review of the manufacturing records showed all requirements were met.Evaluation of the treatment tip confirmed damage along the rf trace of the tip.Investigation found damage to the rf trace are caused by stress concentrations on the flex assembly at the adhesive edge that damage the rf trace, causing arcing and subsequent burn-through of the flex circuit membrane.Based on the available information, this event was most likely caused by damage on the treatment tip.Correction: medical device problem code 2: reported in error and revised to 2942 flare or flash.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 north creek pkwy n; ste 100; bothel WA 98011
• MDR Report Key: 11127932
• MDR Text Key: 225511332
• Report Number: 3011423170-2021-00003
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 12/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other