MAUDE Adverse Event Report: SOLTA MEDICAL, INC THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number TT4.00F6-900

Device Problem Pitted (1460)

Patient Problem Erythema (1840)

Event Date 02/03/2022

Event Type  malfunction  

Event Description

Customer reported that their patient underwent a thermage flx treatment after which it was observed there were small red spots on the patients right side abdomen.It was also noted that the system displayed the error code for "tip too warm" during the abdomen treatment.The customer reported the spots appear to correspond to where the center of the tip was placed on each treatment site.A review of the clinical details and available patient photos was completed by a medical reviewer and it was determined no serious injury was experienced in this case.

Manufacturer Narrative

Treatment tip and system data logs were returned and evaluated.Evaluation of the treatment data indicates that the system and hand piece performed as expected during treatment.The tip passed thermistor testing.The tip failed the leak test.The tip failed visual inspection due to the observance of dielectric breakdown beginning to form on the radio frequency trace.No dents or scratches were observed.No functional testing was possible due to the condition of the returned device.A review of the device manufacturing record is underway.

Manufacturer Narrative

Service re-evaluated this case and it was determined that no dielectric breakdown was found on the tip.The information provided does not suggest this incident may have caused or contributed to a death, serious injury or a serious deterioration in state of health.This event is no longer deemed reportable.

• Brand Name: THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES
• 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; bothel WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st louis, MO 63122
• MDR Report Key: 14372102
• MDR Text Key: 291482030
• Report Number: 3011423170-2022-00050
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TT4.00F6-900
• Device Catalogue Number: TT4.00F6-900
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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