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

Model Number TTNS3.00E4-1200

Device Problems Dent in Material (2526); Arcing (2583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2022

Event Type  malfunction  

Event Description

A user facility reported a dented thermage treatment tip.The cpt thermage treatment tip was evaluated and dielectric breakdown was observed.

Manufacturer Narrative

The tip passed the flow and thermistor tests but failed the leak test.The tip failed visual inspection as there was both a dent in the middle of tip surface as well as dielectric breakdown observed.No functional testing was performed due to dielectric breakdown.Service confirmed dielectric membrane breakdown on the tip.Breakdown of the 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 could possibly cause patient burns.A review of manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.It is unknown how the dielectric breakdown occurred as all treatment tips are visually inspected prior to packaging.No corrective action is required.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, WA 63122 ; 6362263220
• MDR Report Key: 15756995
• MDR Text Key: 307209308
• Report Number: 3011423170-2022-00140
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• 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