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

Model Number	TTNS3.00E4-1200
Medical Device Problem Codes	Crack (1135); Use of Device Problem (1670)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Distress (2329); Skin Burning Sensation (4540); Nodule (4551); Swelling/ Edema (4577)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two thermage ctp tips were returned for evaluation.Evaluation of both the treatment tips found no issues related to this event.Both tips passed the leak, the thermistor, and visual testing.No dents, scratches, blemishes or dielectric breakdown was observed.Functional testing was performed (50 treatments) with no errors or other issues observed.Service was unable to confirm the customer's complaint of a small crack on the tip membrane.According to thermage cpt system user manual pain, surface irregularities, and swelling are known possible adverse patient reactions to thermage cpt treatment.Surface irregularities are variously described as (localized) ¿small dents in the surface of the skin,¿ ¿rippling,¿ ¿ridging,¿ ¿waffle patterns¿, or ¿fat loss¿ (covering a larger surface area).Frequently, surface irregularities are not evident immediately post-treatment but show up later (1 or more months post-treatment).In most cases solta recommends that surface irregularities be monitored for a period of six months post onset.Tissue fillers may be considered as a treatment option if the condition does not resolve on its own.Mild/moderate pain during treatment is common and expected during treatment.Typically, the discomfort is temporary during the procedure and localized within the treatment area.Rarely, patients have reported transient aching in the treatment area lasting up to several months.No nonconformities or anomalies were 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.The data logs were just uploaded and will be reviewed.A supplemental report will be filed when the data has been read.
Event or Problem Description
A user facility reported that a patient was developing "irregular bumps/swollen spots" during a thermage cpt face treatment.The patient had indicated to the customer of feeling an initial stinging sensation.The customer stopped the treatment after noticing the skin condition.The patient was also burned on the left side of her face near the orbital rim.Available pictures were reviewed by the medical reviewer and burned areas are visible on left upper side of the face and forehead.Erythema is visible on forehead, and both cheeks.The patient was administered 10mg oxycodone by mouth + 500mg tylenol by mouth + 1mg ativan by mouth + 50mg gravol.Secondary intervention (ointments, medications, etc.) included applying a cooling pack to the area for 20 minutes and then performing a jet peel hale derma infusion.The patient was also sent home with hydrogel (kept cold).The patient was upset as there may be possible scarring.Multiple unspecified tip-related error codes appeared during treatment despite trying different handpieces.The customer then switched to a different thermage ctp tip and the error codes were resolved.Upon visual inspection, the customer discovered a small crack near a corner of the tip membrane of the first tip.No other treatments (besides thermage) were being performed in the same area where the symptoms were reported, nor has the patient undergone any other treatments in the same symptom area within the past 30 days.This incident is said to have occurred at about 388 pulses with the highest energy level of 2.5 j.Solta medical cryogen and 1.5 bottles of coupling fluid were used during this treatment.The treatment tip surface inspected prior to use and there was nothing noticed prior or during treatment.The treatment tip surface was re-inspected during the treatment with each pass around 10-20 pulses, and checked in between for hand/arm posture changes, and was also checked after each error code.This is the first time this treatment tip was used.
Additional Manufacturer Narrative
Correction: type of investigation - 4121 was reported on initial for evaluation of the datalogs but it had not been performed and then was not able to be performed.Code 4121 has been removed.The datalogs were not available for analysis, as the returned logs did not contain the treatment information, and the provider stated that no more logs are available for return.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.Based on the available information, no causal factors can be determined, and no conclusions can be found.No capa is necessary at this time.
Additional Manufacturer Narrative
This event no longer meets reportability requirements, as a serious injury did not occur.The conclusions from our previous submission remain unchanged.
Event or Problem Description
Available information was received and reviewed.It is reported that the patient's skin has recovered and there will be no scarring.After further evaluation of the case, review of patient images, and consideration of the full recovery without scarring, and the noted treatment - which does not exceed the standard of care, the case was downgraded to "not serious".Therefore, this case no longer meets the requirement for reporting.

• 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 north 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: 20930635
• Report Number: 3011423170-2024-00234
• Device Sequence Number: 8285726
• Product Code: GEI
• UDI-Device Identifier: 00850608002421
• UDI-Public: 00850608002421
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2024

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
• Operator of Device: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 01/17/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/14/2025; 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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 Sex: Unknown