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); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Skin Tears (2516); Blister (4537)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

A user facility reported that during a thermage treatment on the face, the patient experienced welts.During the follow-up visit, the physician noted blisters/skin tears on the face area and provided the patient with bacitracin ointment to be used 3-5 days twice a day.The patient's skin is healing.This incident occurred at 300 pulses with the highest energy level used at 3.0.No system errors occurred but it was noticed that this particular patient was ¿welting¿ more than other patients she had treated in the past.The physician inspected the treatment tip and noticed a small hole.

Manufacturer Narrative

The product was returned and evaluated.The tip first used at (9:23:23 pm on 03/15/21) and was used for (800) treatments.The tip passed the flow test, the leak test, and the visual inspection.There was no dents, scratches, blemishes, or dielectric breakdown observed.The tip passed the thermistor test.No functional testing was performed due to event code e173.The data card evaluation revealed the following: 1 - 76 - tip lifted/tilted during rf on - 0.13%; 10 - 131 - underforce during rf on - 1.25%; 8 - 132 - underforce during post cool - 1.00%; 8 - 133 - underforce during rewarm - 1.00%.Based on the evaluation of the data, the hp and system performed as expected.Failure to maintain constant force until the tone ends (until the end of post cool state) can result in an unsafe condition.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.The review of the system/data logs does not indicate there is any handpiece or system issue present.The plant evaluation is underway.

Manufacturer Narrative

Correction to h10: dielectric breakdown was observed.A new high magnification picture was produced that changed the interpretation of the evaluation.The tip passed the flow test, the leak test and the thermistor test.The tip failed the visual inspection for a burned spot on the tip of the surface as dielectric breakdown was observed.No functional testing was performed due to e173 and a burn spot on tip surface.The plant evaluation is underway.

Manufacturer Narrative

The treatment tip and datacard logs were returned for evaluation.Based on the evaluation of the datacard, the handpiece and system performed as expected.During evaluation of the treatment tip, service found damage to the tip membrane.Based on the available information, the hole in the tip membrane most likely contributed to this event.It is unknown what caused this damage in the membrane.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).A review of the 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.Complaint type identified within risk analysis and performing within anticipated rate.Trending will be performed to monitor this issue.No further action is required at this time.

• 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; bothel WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC.; 11720 north creek pkwy n; ste 100; bothel WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122
• MDR Report Key: 11979571
• MDR Text Key: 255611670
• Report Number: 3011423170-2021-00059
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• 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
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• 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