The data log and treatment tip from the event were returned and evaluated.The data log showed several force related errors had occurred during treatment.Errors indicate a recoverable problem that requires operator intervention.If the error occurs during a radio-frequency treatment, the radio-frequency 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 the data, the handpiece and system performed as expected.Evaluation of the treatment tip found no issues with related to this event.The tip passed flow, leak, and thermistor testing and visual inspection.No dents, scratches, blemishes or dielectric breakdown was observed.Functional testing could not be performed due to all treatments being used.Burns and blisters are known possible adverse patient reactions to thermage cpt treatment.Thermage system technical user¿s manual states 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.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Review of manufacturing records show final manufacturing test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record for the serial number.Based on the available information, this event is a known possible reaction to treatment.No corrective action is necessary at this time.
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