Brand Name | NCONTACT SURGICAL LLC |
Type of Device | SUBTLE CANNULA W/GUIDE 30CM KIT |
Manufacturer (Section D) |
NCONTACT SURGICAL LLC/ ATRICURE, INC. |
raleigh NC 27601 |
|
MDR Report Key | 6435749 |
MDR Text Key | 71044756 |
Report Number | MW5068655 |
Device Sequence Number | 1 |
Product Code |
OCL
|
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
03/23/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/23/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | CSK-6130 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 66 YR |
Patient Weight | 109 |
|
|