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

Model Number TTNS3.00E4-900

Device Problem Circuit Failure (1089)

Patient Problem Blister (4537)

Event Date 01/19/2022

Event Type  malfunction  

Manufacturer Narrative

The treatment tip and data logs were returned and evaluation has been completed.The system has software safeguards that will trigger error/event codes when the system is outside of acceptable limits.Evaluation of the system data showed the hand piece and system performed as expected.The tip passed flow, leak, and thermistor testing.The tip failed visual inspection due to the observance of dielectric breakdown beginning to occur.No dents or scratches were observed.No functional testing could be completed due to the condition of the returned device.A review of the device manufacturing record is in progress.

Event Description

A doctor reported that following a thermage cpt facial treatment the treatment tip membrane felt thin and that they had observed a burnt paste smell during the procedure.The treatment was performed at energy level 3.0-3.5 with ample coupling fluid applied throughout.The tip was inspected prior to use with no abnormalities noted.After about 800 pulses the doctor noted an abnormal smell and re-inspected the treatment tip.The doctor noted the membrane was not damaged but felt thin to the touch.During treatment there was no adverse patient reaction, however shortly after treatment small blisters were noted on the left lower jaw.Patient was treated with cold compress.The patient status was noted as recovering.A medical review of the clinical information was completed and it was determined the information does not suggest serious injury occurred.

Manufacturer Narrative

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.With respect to the cpt system, solta recommends that a tip membrane inspection be performed at the outset of the procedure and every 50 (fifty) pulses thereafter.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.Investigation found stress concentrations on the flex assembly at the adhesive edge that damaged the rf trace, causes arcing and subsequent burn-through of the flex circuit membrane.Based on the available information, this event was most likely caused by damage on the tip membrane however the root cause of the damage could not be determined.

• Brand Name: THERMAGE CPT SYSTEM
• 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: 13956995
• MDR Text Key: 288689793
• Report Number: 3011423170-2022-00032
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/25/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 05/27/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• 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
• Treatment: TOPICAL ANESTHETICS
• Patient Sex: Female