Model Number FUSION |
Device Problem
Imprecision (1307)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient weight not available from the site.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.
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Event Description
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A medtronic representative reported that, while in the procedure in mdr 1723170-2017-04314, an imprecision was observed when utilizing the straight suction.The surgeon opted to complete the procedure without the use of the navigation system.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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A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.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.
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Manufacturer Narrative
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Additional information: patient weight provided.
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Search Alerts/Recalls
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