Model Number FUSION |
Device Problem
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/20/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Patient weight not available from the site.Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.No evaluation has been performed as no confirmation has been provided by the site to have a medtronic representative perform a system checkout and evaluation.Site has not confirmed service.
|
|
Event Description
|
A site representative reported that, while in a functional endoscopic sinus surgery (fess), the navigation system exited the application software without prompt from the user.There was no reported impact on patient outcome.No additional information was provided.
|
|
Manufacturer Narrative
|
Additional information: the udi number and device manufacture date have been received and the fields populated with the information.
|
|
Manufacturer Narrative
|
A software analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.
|
|
Search Alerts/Recalls
|