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

Model Number TTNS3.00E4-1200

Device Problem Flare or Flash (2942)

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

Event Type  malfunction  

Manufacturer Narrative

The product was returned and evaluated.Burnt traces were confirmed on the surface of the tip.The tip start time was 3:5:18 am on (b)(6) 2021 and was used for 905 treatments.The tip passed the flow test and failed the leak test.The tip failed visual inspection for burnt trace on the tip surface.Dielectric breakdown was observed.The tip passed the thermistor test.Functional testing was not performed due to the burnt trace on the tip surface.The plant evaluation is underway.

Event Description

A user facility reported they saw a light from the thermage tip and stopped using the tip.The tip was inspected and no abnormalities were noted.There was no patient injury.

Manufacturer Narrative

Service confirmed burnt radiofrequency trace on the tip membrane which most likely caused the reported issue during treatment.Investigation found glowing or sparking from the tip membrane are 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.Defects on the tip membrane can lead to a raise in temperature of the tip during treatment and can potentially cause patient burns.This evaluation confirms customer¿s account of possible light from the tip membrane during treatment.No patient injury was reported during treatment.A review of the manufacturing records showed all requirements were met.All treatment tips are visually inspected for defects during manufacturing and packaging.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record for serial/lot number: (b)(6).

• 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; bothel WA 98011
• MDR Report Key: 12234124
• MDR Text Key: 263796076
• Report Number: 3011423170-2021-00074
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

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: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other