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 Sparking (2595)

Patient Problem Erythema (1840)

Event Date 01/21/2022

Event Type  malfunction  

Event Description

A surgery center reported that during a procedure the treating doctor observed electric leakage from the treatment tip.This event occurred at the 900th rep.The tip was inspected prior to use and no damage was reported.It is unknown if the tip was inspected during the treatment.After the patient¿s issue, the treatment tip was inspected and they reported the tip appears damaged.They reported the patient's face turned red and that the patient reported feeling a pricking sensation.A medical review of the clinical details of this event was completed and it was determined that no serious patient injury was experienced.

Manufacturer Narrative

The treatment facility indicated they retained the treatment tip.The product has been requested, but not yet received.A review of the manufacturing records is in progress.Based on available information no cause can be established and no conclusions can be drawn.

Manufacturer Narrative

The data-card logs did not have treatment details and the tip was not returned for evaluation, therefore we could not confirm the customers account of tip damage with electric leakage.According to thermage cpt system technical user's manual redness is a known possible patient reaction to thermage treatment.Erythema or blanching may occur in mild form and typically resolve within a few hours.However, on rare occasions, erythema has been reported to last longer.Blanching usually resolves within twenty-four hours.A review of the manufacturing records showed all requirements were met.Based on the available information, no causal factors can be determined and no conclusions can be drawn.

• 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 n creek parkway n; suite 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 goodman st n; rochester, NY 14609
• MDR Report Key: 13794471
• MDR Text Key: 287332441
• Report Number: 3011423170-2022-00024
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2020
• 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