Model Number S7 |
Device Problem
Poor Quality Image (1408)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient identifier could not be obtained.A medtronic representative went to the site to test the equipment.Testing revealed that the system was functioning as intended.The system then passed the system checkout and was found to be fully functional.No parts were returned for analysis.Device manufacturing date was unavailable.
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Event Description
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Medtronic received information regarding a navigation device being used for a cranial resection procedure.It was reported that when the microscope was connected with the system, but not when the two were disconnected, there was a ¿dark area¿.There were a lot of very little white dots in the area, like some kind of snow artifact.But if the microscope didn¿t connect with navigation, there were no such dots in that area.There was no patient impact reported.
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Manufacturer Narrative
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Additional information: manufacture date provided.Correction: unique device identification(udi) updated to proper value.
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Manufacturer Narrative
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Medtronic received information that the troubleshooting did not restore functionality to the navigation system.It was reported that the scope screen for the microscope was displayed without proper display functionality.It was reported that the computer of the navigation system was replaced without resolution.The display would restore functionality when selecting the proper procedure, but following an exit from the application software, the display would not work.
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Manufacturer Narrative
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Additional information: medtronic received information that the external microscope communication cable was replaced without resolution.
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Manufacturer Narrative
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Software analysis was performed.The cause of the issue was unable to be determined.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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