Brand Name | 2.9MM PERCUTANEOUS SHAFT, 29CM LENGTH |
Type of Device | ELECTROSURGICAL,CUTTING&COAGULATION |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
research triangle park NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
rancho el descanso |
|
tecate 21478 |
MX
21478
|
|
Manufacturer Contact |
effie
jefferson
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9194332672
|
|
MDR Report Key | 5887022 |
MDR Text Key | 52500676 |
Report Number | 3003898360-2016-00786 |
Device Sequence Number | 1 |
Product Code |
GEI
|
Combination Product (y/n) | N |
Reporter Country Code | EZ |
PMA/PMN Number | K153063 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
07/19/2016 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/09/2019 |
Device Catalogue Number | PCVSH3 |
Device Lot Number | 73B1600168 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/25/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/19/2016
|
Initial Date FDA Received | 08/18/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/05/2016 |
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 |