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

Model Number TTNS3.00E4-1200

Device Problem Pitted (1460)

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

Event Date 01/23/2022

Event Type  malfunction  

Manufacturer Narrative

The tip was returned and evaluated.The evaluation revealed that the tip passed flow, leak, and thermistor testing.The tip failed visual inspection due to burnt trace observed on the surface membrane and the observance of dielectric breakdown on the tip.No functional testing can be performed due to dielectric breakdown being observed.The review of the system/data logs does not indicate there is any handpiece or system issue present.A review of the device history records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A distributor reported that during a thermage treatment the patient experienced pain followed by a burnt smell at 900 reps.The physician re-inspected the surface of the tip and noticed that it was broken.The highest energy used was 8.0.There were no system errors during this treatment and it was reported that enough coupling fluid was used.The tip was inspected before and during the treatment at every 100 reps.The practitioner changed the tip and proceeded with the treatment, with no additional issues.The reviewed photograph showed inflammation and small scabs that are visible on the patient''s cheek.There was no serious injury.

Manufacturer Narrative

Service confirmed damage to the tip membrane along the radio frequency trace.Breakdown of the dielectric material 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.Defects on the tip membrane can lead to a rise in temperature of the tip during treatment and can potentially cause patient burns.A review of the manufacturing records showed all requirements were met.A medical review of the case determined that this event was not a serious injury.Based on the available information, this event was caused by damage on the tip membrane.

• Brand Name: THERMAGE CPT SYSTEM
• 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: jennifer gamet ; 1400 goodman street north; rochester, NY 14609 ; 5853386853
• MDR Report Key: 13955409
• MDR Text Key: 288689183
• Report Number: 3011423170-2022-00031
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K1324312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• 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
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1