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

Model Number TTNS3.00E2-1200

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

Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685); Blister (4537)

Event Date 10/30/2023

Event Type  Injury  

Event Description

A user facility reported prolonged skin redness and a possible burn to the patient's mid abdomen during an abdominal thermage cpt treatment.The provider noted using a non-vibrating 3.0 cm body tip.The first row was treated at 4.0 energy.During the treatment it was observed that the skin post-pulse was unusually redder in color than expected.The reporter believed this to be a blister and the skin was not raised.After observation of the redness, the provider changed to an energy level of 3.0 after which post- pulse skin redness was not as red as it had been at the 4.0 energy setting.The provider went down to 2.5 jules and marks appeared during the treatment but were gone the next day.The issues were observed 76 pulses into the treatment using a stamping method.No other treatments (besides the one reported) were being performed in the same area where symptoms were reported.No system errors occurred, nor was anything out of the ordinary noticed during treatment.Solta medical cryogen and coupling fluid were also used during this treatment.The treatment tip was inspected prior to use and every couple of pulses during the treatment (as redness from one pass was noted) and no anomalies were identified.This treatment tip had not been used on other patients.One day after treatment the redness on the lower side of the abdomen was gone, but six slightly raised lines on the upper side abdomen were still there a few days post-treatment.The outcome is unclear at this time, but it was noted that the patient is healing.Available pictures were reviewed by the solta medical reviewer.The time and date are not reported on the pictures.Erythema and small burned areas are visible on one side of the abdomen.No blister is present.No medical intervention/additional treatment as a result of the patient injury was reported.Multiple requests have been made for more information regarding patient outcome, but no reply has been received.

Manufacturer Narrative

The product has been requested.The investigation in underway.

Manufacturer Narrative

Correction: d4 serial number - from (b)(6) to (b)(6), h4 4.Device manufacture date - from (b)(6) 2023 to (b)(6) 2023 the datacard was returned and evaluated; the logs showed the following errors occurred during treatment: quantity - error id - description - percent of reps 2 - 132 - underforce during post cool - 2.63% 2 - 133 - underforce during rewarm - 2.63% 3 - 136 - hp button released during post-cool - 3.95% based on the evaluation of the data, the handpiece and system performed as expected.Failure to maintain constant force until the tone ends (until the end of post cool state) can result in an unsafe condition.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 handpiece and system performed as expected.The treatment tip was returned and evaluated.The evaluation of the treatment tip found no issues related to this event.The tip passed the leak and thermistor testing.During visual inspection, a dent was found on the tip membrane.Dents do not cause risk to patients since the radiofrequency energy is still able to distribute evenly across the membrane.There is some scarring from the center to the edges of the tip.Functional testing was performed (50 treatments) with no errors or other issues observed.Evaluation of the treatment tip found no issues related to this event.According to thermage cpt system technical user¿s manual, redness is a known possible patient reaction to thermage treatment.Erythema/ blanching may occur in mild form and typically resolve within a few hours.However, on rare occasions, erythema has been reported to last longer (up to several weeks).Blanching usually resolves within twenty-four (24) hours.Based on the available information, redness is known response to treatment.A review of the manufacturing records showed all requirements were met.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.No corrective action is necessary at this time.

• Brand Name: THERMAGE CPT SYSTEM
• 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: 18246309
• MDR Text Key: 329483535
• Report Number: 3011423170-2023-00103
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E2-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2023
• 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