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

Model Number TTNS3.00E4-900

Device Problems Material Discolored (1170); Material Puncture/Hole (1504)

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

Event Date 02/22/2023

Event Type  malfunction  

Manufacturer Narrative

The treatment tip was evaluated by service, and it was confirmed that there was dielectric breakdown on the membrane.The tip passed the flow, leak, and thermistor tests.The tip failed visual inspection for a burn on tip surface as dielectric breakdown was observed.Functional testing was unable to be performed due to the burn on the tip surface.This confirms the customer report of damage to the tip.Solta medical has confirmed a low incidence (less than 1% of the total estimated number of treatments) of potential risk to patients associated with dielectric membrane breakdown of the membrane of the treatment tip which contacts the patient during the thermage cpt procedure.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 system logs were not available for analysis.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should the system be outside of the acceptable limits.It is the responsibility of the customer to provide the data card and they have not done so; as such, service is unable to provide a summary of the system/handpiece data.Both the thermage user manual and technical bulletin tb-19 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.In addition to recommending frequent tip membrane inspection, solta emphasizes its recommendation to carefully monitor the condition of the patient¿s skin during treatment.In the case of a damage to membrane, the clinician may notice the onset of small burns which would be evidenced by small residual focal red marks or white spots.Should this occur, it is up to the clinician¿s professional discretion to determine whether to continue treatment after replacement of the compromised tip.Burns are known possible adverse patient reactions to thermage treatment.Thermage system technical user¿s manual states 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.A review of the manufacturing records showed 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/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, this event was most likely caused by damage to the tip.It is unknown how damage to the treatment tip occurred as all treatment tips are visually inspected during manufacturing.No corrective action is required.

Event Description

A user facility reported that during a thermage cpt treatment, a patient experienced red edematous papules with skin lesions on the patient''s left cheek.The physician checked the treatment tip and found black holes on the membrane of the tip.It was also reported that there is no permanent damage.This case was reviewed by the medical reviewer and deemed not serious as the information does not suggest a serious injury occurred.The thermage cpt treatment tip was returned for an evaluation and dielectric breakdown observed.

• Brand Name: THERMAGE CPT SYSTEM TIP
• 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
• MDR Report Key: 16597502
• MDR Text Key: 312225806
• Report Number: 3011423170-2023-00039
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2022
• 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