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

Model Number TTNS3.00E4-1200

Device Problem Material Puncture/Hole (1504)

Patient Problem Burn(s) (1757)

Event Date 02/09/2024

Event Type  Injury  

Event Description

A user facility reported burns to the left side of a patient's face during a thermage cpt treatment.The patient experienced burns on the left side of the face during a thermage cpt face procedure.The event was treated with cold air (zimmer) and exosomes.The patient was sent home with instructions for post care.Available pictures were reviewed by the medical reviewer and small, crusted wounds are scattered on the patient's left side of the face, cheek and around the lip over chin.It is possible that after this, the scar will have pih and will have to do some bbl treatments to help.The patient has been in the clinic a few times as the provider has requested her to come in for led: red light therapy and apply exosomes and hale derma onto the area.The patient was administered 75mg demerol + 50mg gravol im prior to treatment.No other treatments (besides thermage) were being performed in the same area where the symptoms were reported.The incident occurred at 900 reps and the highest energy level used was 3.5.No system errors occurred, nor was anything out of the ordinary noticed during treatment.However, photos sent in demonstrate damage to the tip.Solta medical cryogen and 2 bottles of coupling fluid were used during this treatment.The treatment tip surface was inspected prior to use and the tip was reported to be fine.The treatment tip surface was also inspected during the treatment 3 times prior to the incident and nothing remarkable was noted.This was the first time this treatment tip was used.Photos of the tip were sent in, and apparent damage was visible on the tip with a hole melted in it.

Manufacturer Narrative

The catalogs were reviewed and the following errors were present: quantity - error id - description - percent of reps 4 - 131 - underforce during rf on - 0.37% 1 - 132 - underforce during post cool - 0.09% 1 - 134 - hp button released during pre-cool - 0.09% 8 - 135 - hp button released during rf - 0.75% 1 - 138 - temperature limit exceeded - 0.09% 1 - 172 - tm2 disconnected - 0.09% 3 - 211 - force too high when button pushed - 0.28% failure to maintain constant force until the tone ends (until the end of post cool state) can result in an unsafe condition.Errors indicate a recoverable problem that requires operator intervention.If the error occurs during a radiofrequency treatment, the radiofrequency delivery will be stopped, then a post-cooling step will be completed prior to generating an ¿error tone¿ and displaying the event code and event message.After the error tone, the system will transition into action required mode and will display text with instructions for the operator indicating what action may be required to resolve the issue.Based on the evaluation of the data, the handpiece and system performed as expected.The tip was returned and evaluated by service.The tip had been used for 1073 treatments.The tip passed the flow, thermistor, and leak test.The tip failed visual inspection as dielectric breakdown and damage was observed.Functional testing was performed (50 treatments) with no errors or other issues observed.During evaluation of the treatment tip, service found dielectric membrane to the tip membrane.Solta medical has confirmed a low incidence (less than 1% of the total estimated number of treatments) of first and second degree patient burns associated with dielectric membrane the membrane of the treatment tip which contacts the patient during the thermage cpt procedure.Breakdown of the 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.Both the thermage user manual and technical bulletin 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.In addition to recommending frequent tip membrane inspection, solta emphasizes its recommendation to carefully monitor the condition of the patient¿s skin during treatment.In the case of a damage to membrane, the clinician may notice the onset of small burns which would be evidenced by small residual focal red marks or white spots.Should this occur, it is up to the clinician¿s professional discretion to determine whether to continue treatment after replacement of the compromised tip.Burns are a known possible adverse patient reaction to the thermage cpt treatment.Thermage system technical user¿s manual states 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.No non-conformities or anomalies were found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, this event was most likely caused by damage to the tip.It is unknown how damage to the treatment tip occurred.All treatment tips are visually inspected during manufacturing.No corrective action is necessary at this time.

• 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 north 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: 18862272
• MDR Text Key: 337185606
• Report Number: 3011423170-2024-00128
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00850608002421
• UDI-Public: 00850608002421
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K173759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2023
• 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
• Patient Sex: Female