The treatment tip was not returned for evaluation as it was discarded by the reporting facility.The data log was reviewed and the following errors occurred during treatment: quantity: (b)(4), error id - ec485, description - err treatment tip too cold - percent of reps: 1.34%.Quantity: (b)(4), error id - ec785, description - err treatment tip lifted prematurely - percent of reps: 1.84%.Quantity: (b)(4), error id - ec78b, description - err treatment tip force low - percent of reps: 0.34%.Quantity: (b)(4), error id - ec78c, description - err treatment tip temp high - percent of reps: 4.86%.Quantity: (b)(4), error id - ec78e, description - err force before activation - percent of reps: 0.34%.When the system detects a condition that interrupts treatment, a system error code is displayed.These system error codes provide an error code number and instructions for the user to respond to the error.In the event of a system error, the user needs to intervene to proceed.Based on the evaluation of the data, the handpiece and system performed as expected.The data log confirmed the customer¿s account of tip too warm error occurring during treatment.If a treatment tip¿s thermistors exceed the maximum temperature limit due to accelerated thermistor temperatures during active mode, the temperature monitor will catch this condition and display a ¿tip too warm¿ error and place the system into a safe state.This condition presents no patient risk.According to thermage flx user manual, burns are a known possible side effect during a thermage flx treatment.The procedure produces heating in the upper layers of the skin and may cause 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.In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device.Based on the evaluation of the data, the handpiece and system performed as expected.The treatment tip was not returned for investigation.Based on the available information, no causal factors can be determined, and no conclusions can be drawn.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.At this time, no corrective action is necessary.
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