Brand Name | PROXIMATE LINEAR STAPLER |
Type of Device | STAPLE, IMPLANTABLE |
Manufacturer (Section D) |
ETHICON ENDO-SURGERY, LLC. |
475 calle c |
guaynabo PR 00969 |
|
Manufacturer (Section G) |
ETHICON ENDO-SURGERY, LLC |
475 calle c |
|
guaynabo PR 00969 |
|
Manufacturer Contact |
milton
garrett
|
4545 creek road ml 120a |
cincinnati, OH 45242
|
5133378865
|
|
MDR Report Key | 5246708 |
MDR Text Key | 32157272 |
Report Number | 3005075853-2015-07531 |
Device Sequence Number | 1 |
Product Code |
GDW
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K020779 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
11/01/2015 |
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 | 05/09/2020 |
Device Catalogue Number | TX60B |
Device Lot Number | M4HN1M |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/10/2015 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/01/2015
|
Initial Date FDA Received | 11/24/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 12/22/2015
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/09/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|