Model Number TT4.00F6-900 |
Device Problem
Pitted (1460)
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Patient Problem
Erythema (1840)
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Event Date 02/03/2022 |
Event Type
malfunction
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Event Description
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Customer reported that their patient underwent a thermage flx treatment after which it was observed there were small red spots on the patients right side abdomen.It was also noted that the system displayed the error code for "tip too warm" during the abdomen treatment.The customer reported the spots appear to correspond to where the center of the tip was placed on each treatment site.A review of the clinical details and available patient photos was completed by a medical reviewer and it was determined no serious injury was experienced in this case.
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Manufacturer Narrative
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Treatment tip and system data logs were returned and evaluated.Evaluation of the treatment data indicates that the system and hand piece performed as expected during treatment.The tip passed thermistor testing.The tip failed the leak test.The tip failed visual inspection due to the observance of dielectric breakdown beginning to form on the radio frequency trace.No dents or scratches were observed.No functional testing was possible due to the condition of the returned device.A review of the device manufacturing record is underway.
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Manufacturer Narrative
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Service re-evaluated this case and it was determined that no dielectric breakdown was found on the tip.The information provided does not suggest this incident may have caused or contributed to a death, serious injury or a serious deterioration in state of health.This event is no longer deemed reportable.
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Search Alerts/Recalls
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