Brand Name | LIGASURE |
Type of Device | ELECTROSURGICAL, CUTTING & COAGULATION & ACCES |
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 |
tracy
landers
|
5920 longbow drive |
boulder, CO 80301
|
3035816943
|
|
MDR Report Key | 14281240 |
MDR Text Key | 290699760 |
Report Number | 1717344-2022-00541 |
Device Sequence Number | 1 |
Product Code |
GEI
|
UDI-Device Identifier | 10884521705913 |
UDI-Public | 10884521705913 |
Combination Product (y/n) | N |
Reporter Country Code | CI |
PMA/PMN Number | K170869 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
05/03/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/04/2022 |
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 | 20390120X |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/14/2022 |
Date Device Manufactured | 02/08/2022 |
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 Sex | Female |
Patient Weight | 110 KG |