Brand Name | ETHICON ETS-FLEX ARTICULATING ENDOSCOPIC LINEAR CUTTER |
Type of Device | LINEAR CUTTER |
Manufacturer (Section D) |
ETHICON-ENDO SURGERY, INC. |
4545 creek road |
cincinnati OH 45242 |
|
MDR Report Key | 5690801 |
MDR Text Key | 46383214 |
Report Number | MW5062571 |
Device Sequence Number | 1 |
Product Code |
GEI
|
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 |
05/19/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/26/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2021 |
Device Model Number | ATS45 |
Device Lot Number | N4L819 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 11 YR |
|
|