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

Model Number TTNS3.00E4-900

Device Problem Material Discolored (1170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2023

Event Type  malfunction  

Event Description

A user facility reported to a distributor that a thermage cpt tip had shadowing/stains (black spots) on the membrane of the tip during a procedure.The tip was returned and evaluated by service, where dielectric breakdown was observed.

Manufacturer Narrative

The thermage cpt tip was returned and evaluated.The tip passed the flow test, leak test, and thermistor test.Functional testing was performed (50 treatments) with no errors or other issues observed.The tip failed visual inspection, as dielectric breakdown was observed.Investigation found that radiofrequency trace damage on the tip membrane is caused by stress concentrations on the flex assembly at the adhesive edge that damaged the radiofrequency trace, causing arcing and subsequent burn-through of the flex circuit membrane.Burnt radiofrequency trace on the tip membrane most likely caused the reported issue during treatment.All treatment tips are visually inspected for defects during manufacturing and packaging.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.There is an existing nc/capa opened for this type of complaint.

• 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; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 north creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 16247404
• MDR Text Key: 309206576
• Report Number: 3011423170-2023-00013
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• 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: 01/10/2023
• 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