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

Model Number TTNS3.00E4-1200

Device Problems Material Discolored (1170); Device Emits Odor (1425)

Patient Problem Erythema (1840)

Event Date 10/24/2022

Event Type  malfunction  

Manufacturer Narrative

Service reviewed the datalogs for this event and based on the evaluation of the data, the handpiece and system performed as expected.However, the system had a low cryogen error at treatment 472.During the evaluation of the treatment tip, service found damage to the tip membrane.The evaluation yielded the following results: the tip passed the flow and leak tests.The tip failed visual inspection for a burn on the tip surface as dielectric breakdown was observed.The tip passed the thermistor test.Functional testing was not performed due to the burn on the tip surface.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.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.According to thermage cpt system technical user¿s manual, erythema / blanching are 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, this event was most likely caused by damage to the tip.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.It is unknown how damage to the treatment tip occurred.All treatment tips are visually inspected during manufacturing.No corrective action is required.

Event Description

A user facility reported and electrical smell during a thermage cpt treatment which resulted in a red spot to the patient''s face.Burn gel was applied and the red spot disappeared.The case was assessed by the medical reviewer and deemed not serious.The product was evaluated by service and dielectric breakdown was found on the thermage cpt tip.

• 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 ; 4254202135
• MDR Report Key: 15821183
• MDR Text Key: 307662371
• Report Number: 3011423170-2022-00150
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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