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

Model Number	TTNS0.25NB1-450
Medical Device Problem Codes	Material Puncture/Hole (1504); Sparking (2595)
Health Effect - Clinical Code	Blister (4537)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported a minor burn with blisters to the lower left eye during a thermage cpt treatment.The burn was reviewed by the medical reviewer and deemed not serious.The user also reported holes and dielectric breakdown of the device tip.Due to the presence of dielectric breakdown, this case is considered reportable.An eye shield was not used.The patient was given a superficial anesthetic.Secondary intervention (ointments, medications, etc.) required to treat this event included ice or heat.It is reported that there will not be any permanent damage or scarring and that the blisters are resolving.Available pictures were reviewed by the medical reviewer and redness and minor blisters are visible under one eye.No other treatments (besides the one reported) were being performed in same area where the symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 90 days.The patient has not had prior aesthetic treatments on this area.The incident occurred after 430 reps.The highest energy level used was 4.5.No system errors occurred nor was anything out of the ordinary noticed during treatment.Solta cryogen and coupling fluid was used.Approximately 15-20 ml of coupling fluid was used during the treatment.The treatment tip surface was inspected prior to use and there was nothing remarkable.The treatment tip surface was inspected during the treatment at about every 200 pulses.This is the first time the treatment tip was used.
Event or Problem Description
Additional information includes the following: all jewelry or body piercings in the treatment area removed prior to the treatment.The patient was alert and able to provide feedback to the clinician during the procedure.The skin was flat during treatment; and the provider was able to maintain good contact throughout treatment.The patient did not apply anything over the counter at home to treat the burn.
Additional Manufacturer Narrative
The datalogs were reviewed the following errors were generated: quantity - error id - description - percent of reps 1 - 112 - rf delivery efficiency error (phase) - 0.22%.3 - 128 - overforce during rf on - 0.67%.11 - 133 - underforce during rewarm - 2.44%.1 - 165 - underforce during pre cool - 0.22%.3 - 310 - st- tip temp too warm - 0.67%.Error indicates a recoverable problem that requires operator intervention.If the error occurs during an radiofrequency treatment, the radiofrequency delivery will be stopped, then a post-cooling step will be completed prior to generating an ¿error tone¿ and displaying the event code and event message.After the error tone, the system will transition into action required mode and will display text with instructions for the operator indicating what action may be required to resolve the issue.Based on the evaluation of data, the system and the handpiece performed as expected.The tip was returned and evaluated.The tip passed flow, leak and thermistor test.The tip failed visual inspection as dielectric breakdown was observed.Functional testing was not performed due to db being visible on this tip.Evaluation of the treatment tip confirmed damage along the radiofrequency trace of the tip.Investigation found damage to the radiofrequency trace is 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.This confirmed the customer¿s account of damage on the tip.Breakdown of the dielectric material, and/or build-up of foreign substance on the dielectric, 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.Radiofrequency trace on the tip membrane can lead to a raise in temperature of the tip during treatment and can potentially cause patient burns.A dent on the tip was also observed during evaluation but this would not cause the reported event.According to thermage system technical user¿s manual, burns, blisters, and redness are known possible adverse patient reactions 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.No non-conformities or anomalies found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, this event was most likely caused by damage on the treatment tip.No corrective action is necessary at this time.

• Brand Name: THERMAGE CPT SYSTEM TIP
• Common Device Name: 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: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 18650127
• Report Number: 3011423170-2024-00124
• Device Sequence Number: 7055899
• Product Code: GEI
• UDI-Device Identifier: 00850608002278
• UDI-Public: 00850608002278
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K173759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: TTNS0.25NB1-450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female