Catalog Number 8065990941 |
Device Problem
Suction Problem (2170)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/01/2018 |
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 additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
A facility representative reported loss of suction with a patient interface during flap creation.Additional information has been requested.
|
|
Manufacturer Narrative
|
Failure analysis shows the reported problem cannot be reproduced with the returned patient interface.No deviation of docking or other issues can be detected.The reported problem cannot be confirmed.No problem with the returned patient interface can be identified.The manufacturer internal reference number is: (b)(4).
|
|
Manufacturer Narrative
|
The root cause could not be identified conclusively.The most possible root cause may be unnoticed movement of the patient during surgery, too much fluid on the eye or docking technique of the surgeon.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|