Type of Device | LAPAROSCOPE, GENERAL AND PLASTIC SURGERY |
Manufacturer (Section D) |
ETHICON ENDO-SURGERY, LLC. |
475 calle c |
guaynabo 00969 |
|
Manufacturer (Section G) |
ETHICON ENDO-SURGERY, LLC. |
475 calle c |
|
guaynabo 00969 |
|
Manufacturer Contact |
milton
garrett
|
475 calle c |
guaynabo 00969
|
5133378865
|
|
MDR Report Key | 8017505 |
MDR Text Key | 125608923 |
Report Number | 3005075853-2018-14045 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
UDI-Device Identifier | 10705036012511 |
UDI-Public | 10705036012511 |
Combination Product (y/n) | N |
PMA/PMN Number | K912492 |
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 |
Report Date |
10/17/2018 |
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 Catalogue Number | EPS07 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/17/2018 |
Initial Date FDA Received | 10/29/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/30/2018 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |