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Model Number A42011A |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2024 |
Event Type
malfunction
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Event Description
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It was reported, the resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs exhibited a broken ceramic tip.The issue occurred during reprocessing.There were no reports of patient harm.
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Manufacturer Narrative
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To date, the device has not been returned.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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