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Model Number SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2022 |
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 10/17/2023, it was reported by a facility representative via (b)(4) that an ar-3373-4002 sheath had a stopcock fall out.This was discovered during an unspecified procedure, with no patient harm.
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Search Alerts/Recalls
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