Model Number INFINITI OZIL |
Device Problems
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/01/2014 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when add'l reportable info becomes available.(b)(4).
|
|
Event Description
|
A customer reported the surgeon was unable to advance to the next surgical step using the footswitch during a procedure.They were able to advance to the next step by pressing the system display.There was no impact to the pt.
|
|
Search Alerts/Recalls
|