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Model Number 9733856 |
Device Problems
Computer Software Problem (1112); Data Problem (3196)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: 9733763, software version (b)(4).A software analysis was initiated to determine the probable cause of the issue through review of the reported 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.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 system being used during a transsphenoidal procedure.It was reported that after verifying, the orthogonal views "navigation" screen was just showing blue.All other buttons appeared normal and they were able to use the mouse and toggle through screens and different layouts, all were just showing a blank blue screen.The surgeon did not want to reboot and opted to bring a new system into the room to continue the procedure.The procedure was delayed by less than one hour and there was no impact on patient outcome.
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Search Alerts/Recalls
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