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

Model Number TTNS3.00E4-1200

Device Problem Material Puncture/Hole (1504)

Patient Problems Erythema (1840); Inflammation (1932); Scarring (2061); Partial thickness (Second Degree) Burn (2694)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

System tip was returned for evaluation.Evaluation revealed the tip failed leak, flow and visual testing.A small tear of the membrane on the edge of the tip was observed.A review of the manufacturing records showed all requirements were met.It is unknown what caused the damage to the tip, the physicians office reported they did not inspect the tip prior to use.All thermage tips are inspected during manufacturing and prior to shipping to customer.Both the thermage user manual and technical bulletin instructs the operator to inspect the treatment tips for any signs of physical damage prior, during, and after treatment.With respect to the cpt system, solta recommends that a tip membrane inspection be performed at the outset of the procedure and every 50 pulses thereafter.Solta emphasizes the recommendation to carefully monitor the condition of the patient¿s skin during treatment.In the case of damage to a tip membrane, the clinician may notice the onset of small burns which would be evidenced by small residual focal red marks or white spots.Based on the available information, the tear in the membrane of the tip most likely contributed to this event.

Event Description

A physician reported that they received a laser treatment on their neck by a registered nurse in their office.The tip was not inspected prior to use.Immediately, the physician experienced discomfort but the treatment continued on for 30 reps.After these reps they examined the tip and observed a tear.The neck began to scab and blister, medical treatment was not provided.Upon follow up it was indicated the physician has scarring on their neck.Updated images were reviewed and erythema and inflammation are visible on the neck.

• 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; 11720 n creek parkway n ste 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609 ; 5853386853
• MDR Report Key: 9637606
• MDR Text Key: 185890208
• Report Number: 3011423170-2020-00014
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• 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
• Patient Outcome(s): Required Intervention