Model Number TTNS3.00E4-1200 |
Device Problems
Pitted (1460); Sparking (2595)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The tip was returned and evaluated.The evaluation revealed that the tip passed leak, flow, and thermistor testing.It failed for visual inspection due to the observance of a broken membrane and dielectric breakdown on the tip.No functional testing could be performed due to dielectric breakdown being observed.A review of the device history records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.
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Event Description
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A physician reported that a spark occurred at 834 reps during a thermage treatment.No patient injury was reported.
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Manufacturer Narrative
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During evaluation of the treatment tip, service confirmed damage of along the radio frequency trace of the tip.This evaluation confirms customer¿s account of damage to the tip membrane during treatment.Defects on the tip membrane can lead to a rise in temperature of the tip and can potentially cause patient burns during treatment.The datacard was not evaluated so it is unclear if any errors occurred that alerted operator.A review of the manufacturing records showed that all requirements were met.No patient injury occurred during treatment.Investigation found flame/spark from tip membrane are caused by stress concentrations on the flex assembly at the adhesive edge that damaged the rf trace, causing arcing and subsequent burn-through of the flex circuit membrane.
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Search Alerts/Recalls
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