Model Number FUSION |
Device Problems
Device Stops Intermittently (1599); Communication or Transmission Problem (2896)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/02/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Patient weight not available from the site.A medtronic representative went to the site to test the equipment.It was reported that the emitter was replaced to resolve the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts have been received by the manufacturer for evaluation.
|
|
Event Description
|
A manufacturer representative reported that, while in a functional endoscopic sinus surgery (fess), the navigation system was intermittently tracking instruments.It was noted that there was no metal interference.There was no reported delay to the procedure due to this issue.There was no reported impact on patient outcome.No additional information was provided.
|
|
Manufacturer Narrative
|
The field generator was returned to the manufacturer for analysis.Analysis found that the issue could not be replicated as the field generator was connected to a test system and the system remained in green status during all of testing.Flexing the cable did not indicate any intermittent opens.
|
|
Search Alerts/Recalls
|