Brand Name | VASCUCLEAR PRECISION BIPOLAR |
Type of Device | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Manufacturer (Section D) |
SORIN GROUP USA, INC. |
14401 west 65th way |
arvada CO 80004 |
|
Manufacturer (Section G) |
SORIN GROUP USA, INC. |
14401 west 65th way |
|
arvada CO 80004 |
|
Manufacturer Contact |
cheri
voorhees, mgr, qual assur
|
14401 west 65th way |
arvada, CO 80004
|
3034676527
|
|
MDR Report Key | 4136415 |
MDR Text Key | 4950434 |
Report Number | 1718850-2014-00331 |
Device Sequence Number | 1 |
Product Code |
GEI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K102983 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician Assistant
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
08/21/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/30/2017 |
Device Catalogue Number | VC15 |
Device Lot Number | 1416700082 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/21/2014
|
Initial Date FDA Received | 09/18/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 06/01/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|