Brand Name | ATRICURE BIPOLAR SYSTEM |
Type of Device | ATRICURE BIPOLAR SYSTEM |
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 | 11357727 |
MDR Text Key | 232802251 |
Report Number | 3011706110-2021-00008 |
Device Sequence Number | 1 |
Product Code |
OCL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K110117 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/22/2021 |
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 Expiration Date | 12/01/2022 |
Device Model Number | EML2 |
Device Catalogue Number | A000467 |
Device Lot Number | 99689R |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/04/2021
|
Initial Date FDA Received | 02/22/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 04/17/2020 |
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 |
Treatment | MID1, MAX5, PROV |
Patient Outcome(s) |
Life Threatening;
Required Intervention;
|
|
|