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 Pitted (1460)

Patient Problems Erythema (1840); Swelling/ Edema (4577)

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

The treatment tip was received and evaluated.The tip failed leak test and visual inspection.No dents or scratches were observed however, dielectric breakdown was observed.The tip passed thermistor testing.Functional testing was not performed due to the tip being expired.An evaluation of the data log shows the first tip worked as expected from beginning to about halfway through the treatment.Then there was an issue with cryogen distribution that seemed like the cryogen line was restricted, reducing flow to the treatment tip and causing the error code indicating "tip too warm" to persist.After replacing the treatment tip, the system performed as expected.The review of the system/data logs did not indicate there were any handpiece or system issues present.The investigation is ongoing.

Event Description

A physician reported that a patient experienced swelling on the right cheek and right side of the neck one day after undergoing a thermage treatment.The patient was administered diazepam prior to the treatment.This was the first time the tip was used.The tip had to be changed during the treatment as the screen kept indicating the tip was too hot.The highest level of energy used was 0.5-1.5.Patient's photos were reviewed indicating this was not a serious injury.Secondary intervention was not required.This treatment involved two treatment tips, this report is for tip one.

Manufacturer Narrative

When the system detects a condition that interrupts treatment, a system event code is displayed.The system provides an event code number with instructions for how to respond, to address the error.In the event of a system event code, customers need to intervene to proceed.There were total of 5 treatments on treatment date.Evaluation found possible issues with the treatment tip in the 4th treatment.The customer was using two treatment tips on that treatment.The datacard log confirmed the customer¿s account of tip too warm errors 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 detect this condition and display a ¿tip too warm¿ error for the user and place the system into a safe state where it can no longer operate until resolved.This condition presents no patient risk.During evaluation of the treatment tip, service found damage to the tip's membrane.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.The thermage user 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.A review of manufacturing records showed all requirements were met.Based on the available information, this event was most likely caused by membrane damage to the treatment tip but the cause of the damage is unknown.All treatment tips are visually inspected during manufacturing.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• 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 parkway n; suite 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 goodman st n; rochester, NY 14609
• MDR Report Key: 14015340
• MDR Text Key: 288621737
• Report Number: 3011423170-2022-00036
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TT4.00F6-900
• Device Catalogue Number: TT4.00F6-900
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female