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

Model Number TTNS3.00E4-1200

Device Problem Sparking (2595)

Patient Problem Abrasion (1689)

Event Date 08/16/2022

Event Type  malfunction  

Manufacturer Narrative

The product was returned and evaluated.Service was able to confirm burnt trace on tip surface.The treatment tip was used for 585 treatments.The tip passed the flow test, thermistor test, but failed the leak test.The tip failed visual inspection for burnt trace on tip surface as dielectric breakdown was observed.Functional testing was not performed due to the burnt trace on the tip surface.Damage to the radiofrequency trace during treatment can cause result in reports of sparking during treatment.Breakdown of the dielectric material, and/or build-up of foreign substance on the dielectric, 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 and can potentially because patient burns or other potential patient risks.According to thermage cpt system technical user¿s manual, burns, redness, and discoloration 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.Cases of hyperpigmentation usually resolve over the course of time (within several months).Evaluation of the system logs were performed and the system has software safeguards (such as a power on self-test) that will trigger error/event codes should the system be outside of acceptable limits.The review of the system/data logs does not indicate there is any handpiece or system issue present.Based on the evaluation of the data, it appears as if the handpiece and system performed as expected.Errors indicate a recoverable problem that requires operator intervention.If the error occurs during an radiofrequency treatment, the radiofrequency 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.Base on the evaluation of data, the hp and system performed as expected.Based on the available information, this event was most likely caused by damage on the tip membrane.A review of the manufacturing records showed all requirements were met.No non-conformities or anomalies found related to this complaint when reviewing the device history record.There is an existing nc/capa opened for this type of complaint.

Event Description

A user facility reported that a thermage treatment tip sparked at pulse 611.This resulted in a scratch mark on the patient''s face which turned white later.The customer immediately went to a new tip and completed the treatment without further incident.The medical reviewer reviewed this case and determined that the scratch mark is not a serious injury.The highest energy level used was 3.5.There were no system errors that occurred, nor was anything out of the ordinary noticed during treatment - aside from the spark.Solta medical cryogen and coupling fluid were used during this treatment - approximately 4 bottles of coupling fluid.The treatment tip surface was inspected prior to use - nothing remarkable.The tip surface was re-inspected during the treatment at about every 20-30 pulses.This was the first time the tip was used.

• Brand Name: THERMAGE CPT SYSTEM TIP
• 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 north creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st louis, MO 63122 ; 6362263220
• MDR Report Key: 15410572
• MDR Text Key: 303538381
• Report Number: 3011423170-2022-00117
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2021
• 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