Catalog Number 220025 |
Device Problem
Defective Device (2588)
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Patient Problem
No Information (3190)
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Event Date 05/09/2014 |
Event Type
Injury
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Event Description
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It was reported that during a surgical procedure, when the physician started to burr the femur, a warning came up on the screen stating that the handpiece had failed.The drill was disassembled, the handpiece was unplugged but none of them fixed the issue.The physician decided to abort the navio procedure and using a competitor device to finish the case.No surgical delay or patient injury was reported.Results of the investigation have concluded that the failure was related to the siu, showing an overcurrent failure, for that reason, the siu is the main device associated with the event instead of handpiece.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation, along with the log files for review, for a prior investigation.There was no serial number provided for the dhr review of the siu so it could not be concluded if the device met the manufacturing specifications.A complaint history review found similar reports of the issue, this issue will continue to be monitored.The surgical technique guide released at the time of the complaint provide instructions troubleshooting information on the navio surgical system to provide solutions for the most common problems.This is an identified failure mode within the risk assessment.The relationship of the device and the reported event has been established.The over current error that occurred was due to an issue in the siu and outdate version of the firmware.As a result, the root cause of the reported event was due to an electrical component failure.
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Search Alerts/Recalls
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