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Model Number SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2024 |
Event Type
malfunction
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Event Description
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On 01/29/2024, it was reported by a sales representative via (b)(4) that an ar-3373-4002 sheath stopcock would not latch to scope.This was discovered during the case.Another device was used to complete the case with no patient harm.
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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.
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Search Alerts/Recalls
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