Brand Name | UNKNOWN LIGASURE INSTRUMENT |
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 | 10714732 |
MDR Text Key | 212387777 |
Report Number | 1717344-2020-01253 |
Device Sequence Number | 1 |
Product Code |
GEI
|
Combination Product (y/n) | N |
Reporter Country Code | SN |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,literature |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/21/2020 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | UNKNOWN LIGASURE INSTRUMENT |
Device Catalogue Number | UNKNOWN LIGASURE INSTRUMENT |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/30/2020
|
Initial Date FDA Received | 10/21/2020 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 53 YR |