Brand Name | REUSABLE ELECTRODE, 10CM, NITINOL |
Type of Device | PROBE, RADIOFREQUENCY LESION |
Manufacturer (Section D) |
MINTA MEDICAL LIMITED |
caddick road |
merseyside knowsley L34 9 HP |
UK L34 9HP |
|
Manufacturer (Section G) |
MINTA MEDICAL LIMITED |
caddick road |
|
merseyside knowsley L34 9 HP |
UK
L34 9HP
|
|
Manufacturer Contact |
stephanie
o' sullivan
|
5050 nathan lane north |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 9744198 |
MDR Text Key | 180519778 |
Report Number | 3004617090-2020-00003 |
Device Sequence Number | 1 |
Product Code |
GXI
|
UDI-Device Identifier | 05415067025180 |
UDI-Public | 05415067025180 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K090608 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
02/24/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | RF-NE-10 |
Device Catalogue Number | RF-NE-10 |
Device Lot Number | M14597 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/05/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/27/2020 |
Initial Date FDA Received | 02/24/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/11/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |