MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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Model Number 9736242 |
Device Problems
Computer Software Problem (1112); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: 9 736226, serial/lot #: software version: (b)(4).A software analysis was initiated to determine the probable cause of the issue.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.(b)(4) are applicable to the software analysis.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the system would not log into the clinical application.It was possible to put in the user password but it would not get past the medtronic further together screen.During troubleshooting, technical services (ts) had the representative log into the system admin to check the operating system and application versions.The application was uninstalled and reinstalled to resolve the issue.There was no patient present when this issue was identified.
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Search Alerts/Recalls
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