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

Model Number TTNS3.00E4-1200

Device Problem Flare or Flash (2942)

Patient Problems Blister (4537); Swelling/ Edema (4577)

Event Date 08/31/2022

Event Type  malfunction  

Event Description

A user facility reported a flash from a thermage cpt treatment tip during a procedure.The physician was treating the right side of the face.After 3 times of normal super pass treatment, there was a flash in the middle of the face.The doctor immediately stopped the operation.Then the doctor smelled a burning smell, and the customer complained that he felt a strong pain on the face.Blisters, erythema, redness and swelling in the treated area were observed.It was also reported that the patient recovered without permanent damage; as such, this event is not considered serious.The patient was administered topical anesthetics.No other treatments (besides thermage) were being performed in the same area where the symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 30 days.The incident occurred at about 5-10 reps and the highest energy level used was 3.5-4.5.No system errors occurred, nor was anything out of the ordinary during treatment aside from the flash.Solta medical croygen and coupling fluid were used during this treatment.The treatment tip surface was inspected prior to use and nothing remarkable reported.The treatment tip surface was re-inspected during the treatment at about every 70reps.This is the first time this treatment tip was used.

Manufacturer Narrative

The data logs were reviewed.Based on the evaluation of the data, the handpiece and system performed as expected.The product has been requested.The investigation is ongoing.

Manufacturer Narrative

The treatment tip was returned and evaluated.Service was able to confirm burnt trace on the tip surface.The tip failed visual inspection for burnt trace on the tip surface, as dielectric breakdown was observed.The tip passed the flow test and thermistor tests; yet it failed the leak test.Functional testing was unable to be performed due to the burnt trace on tip surface.This damage is caused by stress concentrations on the flex assembly at the adhesive edge that damage the radiofrequency trace, causing arcing and subsequent burn-through of the flex circuit membrane.This damaged most likely caused the report of flash in the middle of treatment.Solta medical has confirmed a low incidence (less than 1%) of patient burns associated with radiofrequency trace damage of the treatment tip, which contacts the patient during the thermage cpt procedure.According to thermage cpt system technical user¿s manual, burns are a known possible side effect of 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.Based on the available information, this event was most likely caused by damage on the tip membrane along the radiofrequency trace.There is an existing capa in place for these types of complaint cases.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 15906485
• MDR Text Key: 307892621
• Report Number: 3011423170-2022-00153
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

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: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2021
• 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