A treating facility reported that while performing a thermage cpt treatment, the tip sparked at 1100 pulses.The physician then tried another pulse and the tip sparked again.The highest energy level used was 4.0.There were no errors reported during the treatment.The tip was inspected prior to use then every 50 pulses after.The patient did experience a burn, however it was considered a non-serious injury.
|
H5 correction: initial report selected as "no" corrected to "yes." the data log from the patient event was evaluated and it shows several errors had occurred during treatment.If an error occurs during an radio frequency (rf) treatment, the rf 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 handpiece performed as expected.During evaluation of the tip, service confirmed damage to the tip membrane along the radio-frequency (rf) trace.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.Defects on the tip membrane can lead to a rise in temperature of the tip during treatment and can potentially cause patient burns.This damage can also result in visible sparking coming from the tip.Investigation found stress concentrations on the flex assembly at the adhesive edge that damages the rf trace can cause arcing and subsequent burn-through of the flex circuit membrane.A review of the manufacturing records showed all requirements were met.No non-conformities or anomalies found related to this complaint when reviewing the device history record for the serial/lot number.Final test verification specifications are acceptable.Based on the available information, this event was most likely caused by damage on the tip membrane.Final test verification specifications are acceptable.Thermage cpt system technical user¿s manual instructs the operator to inspect the treatment tips for any signs of physical damage prior, during, and after treatment.With respect to all thermage systems clinicians should frequently inspect the tip membrane during treatment for signs of breakdown and build-up of foreign substances.With respect to the cpt system, solta recommends that a tip membrane inspection be performed at the outset of the procedure and every 50 (fifty) pulses thereafter.According to thermage cpt system technical user¿s manual, 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.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.
|