Catalog Number 6000-007-000 |
Device Problem
Image Display Error/Artifact (1304)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/07/2018 |
Event Type
malfunction
|
Event Description
|
It was reported that during a procedure at the user facility the device is not staying tight, which could lead to inaccuracies.The procedure was completed successfully with the same device without a clinically significant delay; no adverse consequences or medical intervention were reported.
|
|
Manufacturer Narrative
|
Device evaluation: follow-up report submitted to document device evaluation results.
|
|
Event Description
|
It was reported that during a procedure at the user facility the device is not staying tight, which could lead to inaccuracies.The procedure was completed successfully with the same device without a clinically significant delay; no adverse consequences or medical intervention were reported.
|
|
Search Alerts/Recalls
|