Brand Name | ENSEAL X1 |
Type of Device | ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) |
Manufacturer (Section D) |
ETHICON ENDO-SURGERY, LLC |
475 calle c |
guaynabo PR 00969 |
|
MDR Report Key | 10791977 |
MDR Text Key | 214801591 |
Report Number | 10791977 |
Device Sequence Number | 1 |
Product Code |
HGI
|
UDI-Device Identifier | 10705036015024 |
UDI-Public | (01)10705036015024(17)220228(10)U93L1M |
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 |
10/21/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/05/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | NSLX120L |
Device Catalogue Number | NSLX120L |
Device Lot Number | U93L1M |
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 | 10/21/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/05/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 18980 DA |
Patient Weight | 76 |
|
|