Model Number 800CS |
Device Problem
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Event Description
|
A hospital service technician informed that a nurse reported that the system screen got stuck during a procedure.While the surgeon was operating in the posterior segment, the silicone function was selected the and the screen got stuck to vented gas-forced infusion (vgfi) parameter.It was not possible to come back to surgery function.The system had to be restarted to continue the procedure.Additional information has been requested but not received to date.This is one of two reports being filed for this facility.This report is for the first patient.
|
|
Manufacturer Narrative
|
A service visit was scheuled.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Additional information has been requested but not received to date.
|
|
Event Description
|
A hospital service technician informed that a nurse reported that the system screen got stuck during a procedure.While the surgeon was operating in the posterior segment, the silicone function was selected the and the screen got stuck to vented gas-forced infusion (vgfi) parameter.It was not possible to come back to surgery function.The system had to be restarted to continue the procedure.Additional information has been requested but not received to date.This is one of two reports being filed for this facility.This report is for the first patient.
|
|
Manufacturer Narrative
|
A service visit was performed.
|
|
Manufacturer Narrative
|
Evaluation summary: with no additional, related information provided, the customer reported event was not able to be confirmed.The product met specifications at the time of release.The root cause cannot be determined conclusively.
|
|
Search Alerts/Recalls
|