Catalog Number 8000-040-001 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
malfunction
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Event Description
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Per the account, the interference percentage would not go over 85% during the start of a functional endoscopic sinus procedure.Lower interface percentages during the procedure could potentially lead to inaccuracies.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document the device evaluation.
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Event Description
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Per the account, the interference percentage would not go over 85% during the start of a functional endoscopic sinus procedure.Lower interface percentages during the procedure could potentially lead to inaccuracies.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
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Search Alerts/Recalls
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