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

Model Number TT4.00F6-900

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

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

Event Date 10/16/2023

Event Type  Injury  

Manufacturer Narrative

The datalogs were reviewed by service and based on the evaluation of the data, the system and handpiece performed as expected.Two treatment tip temperature errors were reflected in the log findings.The user will want to verify proper treatment technique, position and orientation (with adequate coupling fluid and equal tip to skin contact and pressure).Cryogen appeared to be flowing during the treatment.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.The review of the system/data logs does not indicate there is any handpiece or system issue present.The treatment tip was returned and evaluated.Service was unable to verify the customer complaint.The thermage flx treatment tip was used up and expired.The tip passed the leak test but the tip failed visual inspection for minor blemishes and some scratches on tip surface.No dielectric breakdown was observed.The tip passed the thermistor test.No functional testing was performed due to the tip being used up and expired.According to thermage flx system technical user¿s manual, burns and blisters are known possible patient reaction 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.Final test verification specifications are acceptable.No non-conformities or anomalies 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, no causal factors can be determined and no conclusion can be drawn.No corrective action is necessary at this time.

Event Description

A user facility reported a burn/blister to the submental area 2 days post thermage flx treatment of the face and neck.Available pictures were reviewed by the medial reviewer and a blister is visible on the upper neck.The patient was administered topical blt (benzocaine, lidocaine, and tetracaine) prior to the treatment.The highest energy level used was 2.5.No system errors occurred nor was anything out of the ordinary noticed during treatment.Solta medical cryogen and 1 bottle of coupling fluid were used during this treatment.The treatment tip surface was inspected prior to use with nothing remarkable to report.The treatment tip surface was inspected during the treatment at about every 100 pulses.This was the first time this individual treatment tip was used.No secondary intervention (ointments, medications, etc.) was required to treat this event.

• 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; 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: 18132397
• MDR Text Key: 328065106
• Report Number: 3011423170-2023-00090
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TT4.00F6-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2023
• 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