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 Problems Burn(s) (1757); Erythema (1840); Blister (4537)

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

The data logs and treatment tip were requested to be returned for evaluation however the data logs were not available.The treatment tip was returned to solta medical and an evaluation was performed.The tip passed flow, leak and thermistor testing, however it failed visual inspection.It was discovered the tip had a pin hole burn mark and dielectric breakdown on the membrane.No functional testing could be performed as the tip was expired.Dielectric membrane breakdown of the dielectric material 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.Dielectric membrane breakdown on the tip membrane can lead to a raise in temperature of the tip during treatment and can potentially cause patient burns.The thermage cpt system technical user¿s manual 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.All tips are visually inspected during the manufacturing and packaging process for any signs of damage to the tip membrane.According to thermage cpt system technical user¿s manual, burns are a known possible reaction to 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.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Review of manufacturing records show final manufacturing test verification specifications are acceptable.No non-conformities or anomalies were found related to this complaint when reviewing the device history record for the serial/lot number.Based on the available information, dielectric membrane breakdown to the tip caused this event.No corrective action is necessary at this time.

Event Description

A user facility reported they had performed a full-face thermage treatment on a patient and the patient experienced a burn on their right cheek and forehead following the procedure.Solta medical branded cryogen and 1 bottle of coupling fluid was used with the highest energy level at 4.0.No system issue occurred during the procedure.This was the first time the treatment tip was used.The tip was inspected prior to the treatment, and every 100 pulses with no discrepancies observed.At the end of the procedure it was noticed the patient¿s right cheek and forehead received burns.The patient was treated with an unknown cream at that time.The current status of the patient is described as recovering and not affected by the event.The reporter indicated that there is possibility of hypo or hyper pigmentation.The patient had not undergone any other treatments in the injury area on the day of the procedure or within 90 days prior.Available pictures of the patient injury on the day of the event were reviewed by a solta medical reviewer.It was observed the patient's face was erythematous on both sides.Small blisters were visible on the both cheeks and the left side of their neck.The solta medical reviewer determined no serious injury had occurred.The treatment tip was returned to solta medical and during evaluation, the product service depot found dielectric breakdown was present on the tip membrane.Dielectric breakdown is deemed a reportable malfunction due to the potential to lead to patient burns.

Manufacturer Narrative

The data logs were reviewed and no errors occurred during treatment.Based on available information the handpiece and system performed as expected.The conclusions within the original report submission remain unchanged.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC; 11720 north 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: 17390406
• MDR Text Key: 319790512
• Report Number: 3011423170-2023-00068
• Device Sequence Number: 1
• Product Code: GEI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2023
• 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