Model Number 9735668 |
Device Problems
Imprecision (1307); Poor Quality Image (1408)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No parts have been returned to the manufacturer for analysis.Part not returned.
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Event Description
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Medtronic received information regarding a navigation device being used for a cranial resection.It was reported that images were missing slices along with bad image quality.Site successfully registered the patient but were inaccurate when verifying registration.Auto-refine attempted without resolution.There was no impact to patient.There was a reported delay to the procedure of less than 1 hour due to this issue.
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.Testing revealed that the system performed as intended and no hardware parts were replaced.The system then passed the system checkout and was found to be fully functional.The patient archives were sent to the manufacturer and upon review, it was discovered that the patient had 9 registrations with error metrics above 1.9.All of the trace registrations showed the pattern of the nose off onto the patients left cheek.The model of the exam appeared to have missing slices shown as solid block.The quality of model most likely caused trace registration to be inaccurate.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The navigation system was checked out with no findings.The patient archives were reviewed, showing that the exam was missing slices, and provided photos showed that the exam was labeled as "not optimal for stealth." there were no indications of a software malfunction.Engineering commented that the site did not likely adhere to imaging protocols.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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