Model Number 36725 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that insufficient roll off occurred.A rf3000 radiofrequency generator and an rf probe were selected for a radiofrequency ablation procedure.During the procedure, roll off occurred after 24min.Ablation seemed to take longer than expected before reaching roll off, without the lesion having any particular characteristics.No patient complications were reported.
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Manufacturer Narrative
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Device eval by manufacturer: the device was returned and analyzed by the external manufacturer, stellartech.No problems were found when the device was analyzed and serviced.Performed power and impedance calibration.Checked and passed stress test.Incrementally powered unit from 0w to 200w at 25 and 100 load.No error occurred.
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Event Description
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It was reported that insufficient roll off occurred.A rf3000 radiofrequency generator and an rf probe were selected for a radiofrequency ablation procedure.During the procedure, roll off occurred after 24min.Ablation seemed to take longer than expected before reaching roll off, without the lesion having any particular characteristics.No patient complications were reported.
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Search Alerts/Recalls
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