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

Model Number TTNS3.00E4-900

Device Problem Pitted (1460)

Patient Problems Erythema (1840); Localized Skin Lesion (4542)

Event Date 02/26/2022

Event Type  malfunction  

Event Description

A distributor reported that a user facility performed a thermage treatment on a patient and immediately post procedure, the patient had experienced erythema and pin-point papules on their left cheek and forehead.Solta medical branded cryogen and a sufficient amount of coupling fluid were used during the procedure with the highest level of treatment at 3.0.The physician noted an event code of e138 during treating the left side of the face and forehead.The treatment tip was inspected prior to use and during the procedure every 80-100 pulses with no discrepancies found.The treatment tip was returned to the manufacturer where dielectric breakdown was observed on the tip membrane.Pictures of the patient were reviewed and no serious injury had occurred.

Manufacturer Narrative

Data logs from the treatment were reviewed and based on evaluation of the data, the handpiece and system performed as expected.The treatment tip was returned to the manufacturer where dielectric breakdown was observed on the tip membrane.Functional testing could not be performed as the tip had no more pulses.A plant evaluation is underway.

Manufacturer Narrative

Correction h10: initial mdr was missing full product evaluation."the tip passed the flow test.The tip failed the leak test, the thermistor test, and visual inspection as a dent and dielectric breakdown was observed." the data log was evaluated and showed errors had occurred during treatment.An error indicates a recoverable problem that requires operator intervention.If the error occurs during a radio-frequency (rf) treatment, the rf delivery will be stopped, then a post-cooling step will be completed prior to generating an ¿error tone¿ and displaying the event code and event message.After the error tone, the system will transition into "action required" mode and will display text with instructions for the operator indicating what action may be required to resolve the issue.Based on the evaluation of data the system and handpiece performed as expected.There were no e138 errors listed during this treatment.Breakdown of the dielectric material on the tip 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.Defects on the tip membrane can lead to a raise in temperature of the tip during treatment.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.According to the thermage cpt system technical user¿s manual, redness, burns, and pigment changes are possible reactions to the treatment.Erythema / blanching may occur in mild form and typically resolves within a few hours.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 for the serial/lot number.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, damage to the tip caused this event.No corrective action required.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC; 11720 north creek pkwy north; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC; 11720 n creek pkwy north; suite 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 14380762
• MDR Text Key: 292374499
• Report Number: 3011423170-2022-00052
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-900
• Device Catalogue Number: TTNS3.00E4-900
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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