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Model Number 9733158 |
Device Problem
Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device lot number and unique device identifier (udi) is unavailable.The vertek probe instrument was not returned to the manufacturer for analysis.However, a system checkout performed and found to be functioning as designed.Device manufacturing date is unavailable.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 for a cranial biopsy procedure.It was reported that there was unusual behavior from the probe.It was noted that during the case the site was able to see the reference frame, but the probe was intermittently being recognized by the camera.The site checked the environment for field of view interference and moved the lights out of the way, but this did not resolve the behavior.It was noted that when a sphere was removed the intermittent behavior was resolved, but the site only wanted to continue with all 4 spheres and green status.When the site moved the probe 4 ft away from the patient the camera was able to see the probe without issue.The site was recommended to make sure the spheres were clean and the reference frame was on the opposite side of the probe.When using the probe with an aiming device and trajectory locked, the error to target changed from around 0.6 mm to about 3 mm when the probe rotated in the channel.There was no surgical delay and no impact on the patient outcome.
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Manufacturer Narrative
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A software analysis was initiated.However, the software evaluation found that a probable cause 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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