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Model Number APOLLO RF® I90, ASPIRATING ABLATOR 90° |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2024 |
Event Type
malfunction
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Event Description
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On 02/23/2024, it was reported by a sales representative via (b)(4) that an ar-9831 apollo probe tip fell apart.This occurred during use in a case with no patient effect.
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Search Alerts/Recalls
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