MAUDE Adverse Event Report: SOLTA MEDICAL INC. THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number TT0.25F6-450

Device Problem Excessive Heating (4030)

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

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

The data log from the event was reviewed and showed tip too warm, tuning, and force errors, occurred during treatment.Based on available data the handpiece and system performed as expected.The treatment tip has been requested to be returned but has not yet arrived.The investigation is ongoing.

Event Description

A user facility reported that a patient experienced burns and redness on both of their lower eyelids following a thermage flx treatment.Solta medical branded cryogen and a sufficient amount of coupling fluid was used with the highest level of treatment at 2.0.The patient received treatment to their face and eye areas.During the procedure the customer observed some tip too warm errors had occurred and replaced the tip to resolve.This was the first time the treatment tip was used for treatment.It was inspected prior to use on the patient but it¿s unknown if it was inspected at any time during the treatment.Immediately following the procedure, the patient experienced redness on both lower eyelids.The following day the patient observed blisters in the same area.The patient was prescribed an unknown ointment.The patient also underwent 600 reps of thermage for the facial area on the same day with a separate treatment tip, which reportedly did not overlap with the eye tip treatment area.The patient¿s current status, eight days post treatment, is the injury areas have scabbed and the scabs have started to peel off.It¿s unknown if there will be any permanent damage or scarring.A solta medical reviewer examined photos of the patient injury.Crusted and hyperpigmented areas were observed under both of the eyes.

Manufacturer Narrative

The data log from the event was reviewed and showed tip too warm, tuning, and force errors, occurred during treatment.When the system detects a condition that interrupts treatment, a system error code is displayed.These system error codes provide an error code number and instructions for how to respond to the error.In the event of a system error, customers need to intervene to proceed.Based on the evaluation of the data, the system and handpiece perform as expected.The user will want to verify proper treatment technique, position and orientation (with adequate and equal tip to skin contact and pressure).Cryogen appeared to be properly flowing to the tip.The datacard log confirmed the customer¿s account of a "tip too warm" error occurring during treatment.If a treatment tip¿s thermistors exceed the maximum temperature limit due to accelerated thermistor temperatures during active mode, the temperature monitor will catch this condition and display a ¿tip too warm¿ error and place the system into a safe state.This condition presents no patient risk.The treatment tip was returned and evaluated and it passed leak and thermistor testing.The tip also passed visual inspection.There were no dents, scratches, blemishes, or dielectric breakdown observed.It was noted the tip had only been used for 2 pulses and no issues were found.No functional test was performed due to tip being expired.According to thermage flx user manual, burns and redness are known possible side effects during a thermage flx treatment.The procedure produces heating in the upper layers of the skin, and may cause 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 nonconformities or anomalies were found related to this event when reviewing the device history record.No corrective action is necessary at this time.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• 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: 18867851
• MDR Text Key: 337244595
• Report Number: 3011423170-2024-00129
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00816995021353
• UDI-Public: 00816995021353
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K170758
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TT0.25F6-450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1