Model Number S7 |
Device Problems
Imprecision (1307); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/17/2017 |
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 hardware, software and instruments passed the system checkout.The system was found to be fully functional.The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.No parts were replaced or returned to the manufacturer for evaluation.
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Event Description
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A site representative reported that, while in a procedure, there was an alleged inaccuracy with the navigation system.The suretrak driver was reportedly 2mm off.The arm board also moved during the procedure and the site had to reposition the patient.There was no additional information provided.
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Manufacturer Narrative
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Additional information: patient demographics provided.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.
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Search Alerts/Recalls
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