The treatment tip was returned for evaluation.During evaluation, the tip passed flow, leak, and thermistor testing.Visual inspection found a hole in the treatment tip and damage to the tip membrane (dielectric breakdown).The device history record was reviewed and there were no discrepancies or unusual findings that relate to the reported issue.Breakdown of the treatment tip membrane 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.The thermage user manual and the technical bulletin instruct 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, the manufacturer recommends that a tip membrane inspection be performed at the outset of the procedure and every 50 (fifty) pulses thereafter.In addition, the manufacturer, emphasizes its recommendation to carefully monitor the condition of the patient¿s skin during treatment.In the case of damage to membrane, the clinician may notice the onset of small burns, which would be evidenced by small focal red marks or white spots.Should this occur, it is up to the clinician¿s professional discretion to determine whether to continue treatment after replacement of the compromised tip.Solta also reiterates the importance of clinician attention to treatment error messages provided by the system, in particular messages indicating underforce and lifting irregularities.As with all thermage systems, ensuring perpendicular contact between the handpiece and skin is critical.
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It was reported that red bumps, scabs, and spots were observed on the face and neck.Upon further investigation, the event was deemed not serious, however, evaluation of the returned tip found that the tip membrane had dielectric breakdown.
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