Model Number S7 |
Device Problem
Device Inoperable (1663)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/15/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Udi not available for this system at time of filing.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Onsite functional and visual examination was performed was performed by a manufacturer representative.The system was found to be fully operational.The system passed a system checkout.
|
|
Event Description
|
Medtronic received information regarding a navigation device being used for a cranial biopsy procedure.The event occurred preoperatively while planning and caused a 25-minute delay to the surgery.It was reported that during setup for a case, the system was unresponsive when changing the threshold value of the 3d model.The manufacturer representative hard shut down the system and rebooted it.The system was still unresponsive on the planning task and was unresponsive multiple times.One time, the system fully exited the software and rebooted to the application selection screen.The system took much longer to change screens and boot up.The use of the navigation device was aborted, and the surgery was completed.There was no known impact on patient outcome.
|
|
Manufacturer Narrative
|
Additional information: unique device identification (udi) and device manufacture date provided.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
|