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

Model Number TTNS3.00E4-1200

Device Problems Loose or Intermittent Connection (1371); Sparking (2595)

Patient Problems Pain (1994); Skin Discoloration (2074); Blister (4537)

Event Date 02/20/2022

Event Type  malfunction  

Manufacturer Narrative

The device has been discarded.The data logs have been requested for the event and the investigation is underway.

Event Description

A user facility reported that during a thermage treatment the device showed the tip did not fully attach and there were sparks from the tip when a pulse was delivered.There were no other treatments being performed in same area where symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 30 days.The highest energy level used during treatment was 2.5 and there were no system errors that occurred or anything out of the ordinary.Solta cryogen and sufficient coupling fluid were used during the procedure.The customer stated they had inspected the treatment tip during the procedure two times, and the technician did not observe any discrepancies.This is the first time the treatment tip had been used and the customer discarded the tip afterwards.The customer replaced the tip and there were no more issues with the remainder of the treatment.The patient reported feeling more pain during that time which resulted in post procedure blisters on the patient¿s lower cheek the next day.The patient''s current status is they have recovered from the injury, but there is still some mild discoloration.This event is not considered to be a serious injury, this is being reported for a device malfunction.

Manufacturer Narrative

The data card was returned to the manufacturer however there was no data found for the patient event date.No evaluation of the patient data could be performed.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 CPT SYSTEM TIP
• 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 pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122
• MDR Report Key: 13906271
• MDR Text Key: 288689364
• Report Number: 3011423170-2022-00027
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1