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

Model Number TTNS3.00E4-1200

Device Problem Sparking (2595)

Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685)

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

The product has been requested.The investigation is underway.

Event Description

A user facility reported a spark with a thermage treatment tip.It was also reported that the patient experienced erythema on the face.No secondary intervention was required to treat this event.There were no other treatments (besides thermage) being performed in same area where the symptoms were reported and no other treatments were performed in the same symptom area within the past 30 days.The rep or range of reps/sites occurred at 2.0, the highest energy level used was 3.0.Solta medical croygen and coupling fluid used during this treatment.The treatment tip surface was not inspected prior to use.The tip surface was re-inspected the treatment tip surface during the treatment.

Manufacturer Narrative

The product was returned and evaluated.Service was unable to confirm any functional problem with this tip due to burnt trace on tip surface.The tip is a valid tip verified against the solta database.The tip passed the flow test and failed the leak test.The tip failed the visual inspection for burnt trace on tip surface.Dielectric breakdown was observed.The tip passed the thermistor test.Functional testing was not performed due to the burnt trace on the tip surface.The plant evaluation is underway.

Manufacturer Narrative

Service reviewed the data logs and based on the evaluation of data, the system and the handpiece performed as expected; but not the treatment tip.The customer used two treatment tips for this treatment.The system started to intermittently loose connection to the tm1 in about half of the treatment.Once they switched to different tip, the problem was resolved.Service looked further into the calculated impedance data related to output current and power and everything appeared correctly.Evaluation of the treatment tip confirmed damage along the radiofrequency trace of the tip.Defects on the tip membrane can cause the radiofrequency energy, delivered by the system, to focus in a small area of the membrane, rather than to be uniformly distributed over the entire membrane area and can potentially cause patient burns.This can also cause sparking from the tip during treatment confirming customers report of sparking during treatment.Investigation found damage to the radiofrequency trace are caused by stress concentrations on the flex assembly at the adhesive edge that damage the radiofrequency trace, causing 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 treatment tip.Both the thermage user manual (p009240-06 rev.A) and technical bulletin tb-19 instructs the operator to inspect the treatment tips for any signs of physical damage prior, during, and after treatment.With respect to all thermage systems, clinicians should frequently inspect the tip membrane during treatment for signs of breakdown and build-up of foreign substances.With respect to the cpt system, solta recommends that a tip membrane inspection be performed at the outset of the procedure and every 50 (fifty) pulses thereafter.According to thermage cpt system technical user¿s manual (p009240-06 rev.A) burns, blisters, scabbing, are known possible patient reaction to thermage treatment.The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation.There is a small chance of scar formation.Application of topical steroidal or antibiotic preparations may be of benefit.In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device.A review of the manufacturing records showed all requirements were met.A medical review of this case determined this event was not a serious injury.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record for serial/lot number: (b)(6).No capa is required, since there is no non-conformance.

Manufacturer Narrative

Correction: health effect impact code from 4614 to 4613, investigation findings 1 from 114 to 120, investigation findings 2 from 114 to 174.

• 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 north creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122
• MDR Report Key: 12705451
• MDR Text Key: 278621374
• Report Number: 3011423170-2021-00117
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 11/19/2021; 12/27/2021; 05/10/2022
• Supplement Dates FDA Received: 12/17/2021; 01/21/2022; 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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
• Patient Outcome(s): Other