Model Number FUSION COMPACT |
Device Problems
Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.
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Event Description
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A medtronic representative reported that, while in a functional endoscopic sinus surgery (fess), the navigation system was unable to track instruments.It was reported that the interface box of the navigation system would not communicate.Restarting the navigation system did not resolve the reported issue.It was noted that after disconnecting the emitter, the navigation system displayed that the localizer was not connected.Once switching the universal serial bus (usb) port being used on the navigation system, functionality was restored.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.No additional information was provided.
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Manufacturer Narrative
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Correction: unique device identification (udi) and device manufacture date updated to proper value.
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Manufacturer Narrative
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Patient information was unavailable from the site.
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Event Description
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Medtronic received information regarding a navigation device being used intra-operatively for a functional endoscopic sinus surgery (fess) procedure.It was reported that the navigation device was not tracking any instruments.The emitter details pane stated the box was no communicating.There was a reported delay to the procedure of less than 1-hour and no known impact on the patient outcome.
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Search Alerts/Recalls
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