The tip was returned and evaluated.The tip passed flow, leak and thermistor testing.The tip failed visual inspection due to the observation of dielectric breakdown.Functional testing was performed on the tip with no errors or other issues observed on 50 treatments.A review of the manufacturing records showed all requirements were met.No patient injury occurred during treatment.Service confirmed damage on the tip membrane along the radio-frequency trace.Investigation found flame/spark from the tip membrane are caused by stress concentrations on the flex assembly at the adhesive edge that damaged the radio-frequency trace, causing arcing and subsequent burn-through of the flex circuit membrane.Defects on the tip membrane can lead to a raise in temperature of the tip during treatment and can potentially cause patient burns.
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