Model Number S7 |
Device Problems
Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); 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 03/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A manufacture 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 issue could not be reproduced.No parts have been returned to the manufacturer for evaluation.
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Event Description
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Information was received from a health care professional via manufacturer representative regarding a navigation device being used for in a procedure.It was reported that while setting up for the case, the camera was not able to track any instruments or patient trackers.The representative verified that there was no light interference and the site was using new spheres.The representative entered into the ndi configuration utility and all fields were showing okay under the positioning sensor unit (psu) and camera.A new cable was installed previously.The representative shut down the system from admin and received a system halted error message.A hard shutdown of the system was performed.The system was turned back on and entered the cranial application.The camera was now working without issue.There was a reported delay to the procedure of less than 1 hour due to this issue and no impact on the patient outcome.
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Manufacturer Narrative
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Additional information: the issue occurred during a brain tumor resection.
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Search Alerts/Recalls
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