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

Model Number TTNS0.25NB1-450

Device Problem Material Deformation (2976)

Patient Problems Pain (1994); Superficial (First Degree) Burn (2685)

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

The treatment tip was returned and the evaluation was completed.During evaluation of the treatment tip, service found dielectric breakdown.The tip passed the flow test and thermistor test and failed the leak test.The tip failed the visual inspection as dielectric breakdown was observed.No functional testing was performed due to the dielectric breakdown.According to the thermage cpt system technical user¿s manual, burns are a known possible reaction to treatment.The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.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.Based on the available information, this event was most likely caused by damage on the tip membrane.No corrective action is required.

Event Description

A user facility reported that during a thermage cpt treatment on the left upper and lower eyelid, the patient experienced pain with every pulse.The user facility observed a micro spur on the edge of the treatment tip and noted that the epidermis layer was very mildly burned.The patient recovered and has no scarring.The medical reviewer has deemed this as not serious.The treatment tip was returned to solta for an evaluation and dielectric breakdown was observed.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 15433351
• MDR Text Key: 306175927
• Report Number: 3011423170-2022-00119
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2022

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: TTNS0.25NB1-450
• Device Catalogue Number: TTNS0.25NB1-450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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