Catalog Number 6000-660-000 |
Device Problem
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/16/2018 |
Event Type
malfunction
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Event Description
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It was reported that during a navigation procedure the device lost accuracy.This could lead to the device showing the tool in the incorrect position and causing harm.The procedure was completed successfully with no significant delays or known impact to the patient associated with the event.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document device evaluation results.
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Event Description
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It was reported that during a navigation procedure the device lost accuracy.This could lead to the device showing the tool in the incorrect position and causing harm.The procedure was completed successfully with no significant delays or known impact to the patient associated with the event.
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Search Alerts/Recalls
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