Catalog Number 9735669 |
Device Problems
Device Stops Intermittently (1599); Communication or Transmission Problem (2896); No Visual Prompts/Feedback (4021)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/10/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
A medtronic representative went to site to test the equipment.Representative was unable to replicate the reported issue.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced.No parts have been received by the manufacturer for evaluation.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.
|
|
Event Description
|
A site representative reported that during functional endoscopic sinus surgery (fess), the registration was successful and were able to track instruments.When the ostium seeker was introduced into the sinus site lost tracking.It was reported that the bed did not have metal and the patient was on a head holder.Site used a different medtronic navigation system to complete the procedure.The procedure was completed with the use of navigation.There was a delay of less than 1 hour.No impact on patient outcome.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Coding update.
|
|
Search Alerts/Recalls
|