Brand Name | ETHICON ENSEAL LARGE JAW TISSUE SEALER |
Type of Device | ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) |
Manufacturer (Section D) |
ETHICON ENDO-SURGERY, INC. |
cincinnati OH 45242 2839 |
|
MDR Report Key | 10343704 |
MDR Text Key | 201203096 |
Report Number | MW5095793 |
Device Sequence Number | 1 |
Product Code |
HGI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
07/27/2020 |
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 Expiration Date | 09/30/2021 |
Device Catalogue Number | NSLX120L |
Device Lot Number | T94T1H |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 07/29/2020 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 36 YR |
|
|