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

Model Number TTNS3.00E4-1200

Device Problem Sparking (2595)

Patient Problem Erythema (1840)

Event Date 04/16/2022

Event Type  malfunction  

Manufacturer Narrative

Treatment tip was returned and evaluation completed.The tip passed flow, leak, and thermistor tests.No functional testing was completed due to the condition of the returned device.The tip failed visual inspection due to the observance of dielectric breakdown on the tip membrane.A review of the device manufacturing record has been initiated, but not yet completed.

Event Description

A clinic reported during a thermage cpt procedure a spark was seen from the tip of the device.The clinician reported the patient was treated at a maximum power level of 3.5, ample coupling fluid was used, and that the tip was inspected prior to use and every 20-50 pulses during treatment.No observed abnormalities were reported.Near the end of the treatment a spark was noted and the clinician reduced treatment level to complete treatment.Available pictures were reviewed.Some post inflammatory hyper-pigmented areas are visible.It was determined by the medical evaluator that this does not constitute a serious injury event.

Manufacturer Narrative

A review of the manufacturing records showed that all requirements were met.Service confirmed damage to the tip membrane along the radio frequency trace.Investigation found stress concentrations on the flex assembly at the adhesive edge that damaged the radio frequency trace, causes arcing and subsequent burn-through of the flex circuit membrane.Based on the available information, this event was most likely caused by damage on the tip membrane.The final test verification specifications are acceptable.No non-conformities or anomalies were found related to this complaint when reviewing the device history record.

• 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 n creek parkway n; suite 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 goodman st n; rochester, NY 14609
• MDR Report Key: 14431113
• MDR Text Key: 292806120
• Report Number: 3011423170-2022-00057
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• 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: 04/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1