Brand Name | LIGASURE |
Type of Device | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Manufacturer (Section D) |
COVIDIEN MFG DC BOULDER |
5920 longbow dr |
boulder CO 80301 3299 |
|
Manufacturer (Section G) |
COVIDIEN MFG DC BOULDER |
5920 longbow dr |
|
boulder CO 80301 3299 |
|
Manufacturer Contact |
lisa
hernandez
|
5920 longbow drive |
boulder, CO 80301
|
2034925563
|
|
MDR Report Key | 10769351 |
MDR Text Key | 214118213 |
Report Number | 1717344-2020-01340 |
Device Sequence Number | 1 |
Product Code |
GEI
|
UDI-Device Identifier | 10884521705913 |
UDI-Public | 10884521705913 |
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | K170869 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/02/2020 |
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 |
Health Professional
|
Device Model Number | LF1937 |
Device Catalogue Number | LF1937 |
Device Lot Number | 01210170X |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/15/2020
|
Initial Date FDA Received | 11/02/2020 |
Date Device Manufactured | 04/30/2020 |
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 |