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

Model Number TTNS3.00E4-1200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blister (4537)

Event Date 10/21/2022

Event Type  Injury  

Event Description

The customer reported a day after a patient received a thermage cpt treatment on the right and left side of their face, a few blisters and scabs appeared on their cheek.The patient was given topical anesthetics prior to the procedure and the current status is not known.After approximately 50-60 reps, is when the incident occurred.The highest energy level used during the treatment was level 5.0.Adequate coupling fluid was used during the treatment and there were no error codes during the procedure.The treatment tip was inspected prior to use, as well as every 80 reps during the treatment with no abnormalities noted.

Manufacturer Narrative

The datacard log was returned for an evaluation.Based on the evaluation of the data, the handpiece and system performed as expected.The treatment tip has been requested and is expected to be evaluated.The investigation is ongoing.

Manufacturer Narrative

Correction: g4 pma/510k from k132431 to k173759.The treatment tip from the patient event was returned for evaluation.The treatment tip passed the flow, leak, and thermistor testing, but had failed visual inspection due to a dent and burnt trace on the tip surface.Functional testing was unable to be performed due to the burnt trace on the tip surface.Defects on the tip membrane can cause the radio-frequency 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.Both the thermage user manual and technical bulletin, instruct 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, burns, blisters, and scabbing, are known possible patient reactions 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.A review of the manufacturing records showed all requirements were met.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.Investigation has found damage to the radio-frequency trace is caused by stress concentrations on the flex assembly at the adhesive edge that damage the radio-frequency 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.There is an existing capa opened for this type of complaint.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC; 11720 n 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: sundeep jain ; 11720 n creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 15887247
• MDR Text Key: 304539577
• Report Number: 3011423170-2022-00152
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2021
• 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