Brand Name | ENSEAL |
Type of Device | ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) |
Manufacturer (Section D) |
ETHICON ENDO-SURGERY, LLC |
4545 creek rd. |
cincinnati OH 45242 |
|
MDR Report Key | 8296581 |
MDR Text Key | 134727284 |
Report Number | 8296581 |
Device Sequence Number | 1 |
Product Code |
HGI
|
UDI-Device Identifier | 10705036000297 |
UDI-Public | (01)10705036000297 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/22/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 16ETRIO335H |
Device Catalogue Number | ETRIO335H |
Device Lot Number | R9513K |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/22/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 02/01/2019 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 02/01/2019 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|