Brand Name | LIV |
Type of Device | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
Manufacturer (Section D) |
ATRICURE, INC. |
2603 camino ramon |
san ramon CA 94583 |
|
MDR Report Key | 5438547 |
MDR Text Key | 38253289 |
Report Number | 5438547 |
Device Sequence Number | 1 |
Product Code |
DWS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
11/16/2015 |
2 Devices were Involved in the Event: |
1
2
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Catalogue Number | 340-7475 |
Device Lot Number | 001-340-7475 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/16/2015 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/16/2015 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 02/16/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 02/17/2016 03/10/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|