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Model Number APOLLORF¿ XL90, ASPIRATING ABLATOR 90° |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2023 |
Event Type
malfunction
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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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Event Description
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On (b)(6) 2023, it was reported by a sales representative via sems that an ar-9821 apollo probe is showing an error message, and wires were exposed.This was discovered during an unspecified time with no patient effect.
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Search Alerts/Recalls
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