Catalog Number 6000-655-000 |
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 11/15/2017 |
Event Type
malfunction
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Event Description
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It was reported that before a navigation procedure the cranial map software would not register as intended.Permanent impairment of body function or permanent damage to a body structure can occur as a result of the software being inaccurate.After multiple attempts the process did work and the procedure was completed successfully without any known patient effect or surgical delay.
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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 before a navigation procedure the cranial map software would not register as intended.Permanent impairment of body function or permanent damage to a body structure can occur as a result of the software being inaccurate.After multiple attempts the process did work and the procedure was completed successfully without any known patient effect or surgical delay.
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Search Alerts/Recalls
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