Brand Name | EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX |
Type of Device | EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX |
Manufacturer (Section D) |
ATRICURE, INC. |
7555 innovation way |
mason OH 45040 |
|
Manufacturer (Section G) |
ATRICURE, INC. |
7555 innovation way |
|
mason OH 45040 |
|
Manufacturer Contact |
john
ehlert
|
7555 innovation way |
mason, OH 45040
|
5136448220
|
|
MDR Report Key | 15988202 |
MDR Text Key | 305529305 |
Report Number | 3011706110-2022-00045 |
Device Sequence Number | 1 |
Product Code |
OCL
|
UDI-Device Identifier | 30840143903827 |
UDI-Public | (01)30840143903827(17)250601(10)121068 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K193162 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/15/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | CDK-1413 |
Device Catalogue Number | CDK-1413 |
Device Lot Number | 121068 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/17/2022
|
Initial Date FDA Received | 12/15/2022 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 06/22/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Life Threatening;
Hospitalization;
|
Patient Age | 79 YR |
Patient Sex | Female |