Brand Name | GYNECARE VERSAPOINT II BIPOLAR ELECTROSURGERY SYSTEM |
Type of Device | COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 0151 |
|
Manufacturer (Section G) |
ETHICON INC.-GYRUS MEDICAL LTD |
fortran road, st. mellons |
|
cardiff CF3 O LT |
UK
CF3 OLT
|
|
Manufacturer Contact |
guillermo
villa
|
route 22 west po box 151 |
somerville, NJ 08876
|
9082180707
|
|
MDR Report Key | 5140156 |
MDR Text Key | 27917277 |
Report Number | 2210968-2015-14803 |
Device Sequence Number | 1 |
Product Code |
HIH
|
Combination Product (y/n) | N |
PMA/PMN Number | K111751 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Report Date |
05/21/2015 |
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 Catalogue Number | 00465 |
Device Lot Number | GY1120588 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/14/2015 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 10/09/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/01/2011 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|