Brand Name | SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES |
Type of Device | INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - MARLBOROUGH |
100 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC - MARLBOROUGH |
100 boston scientific way |
|
marlborough MA 01752 |
|
Manufacturer Contact |
nancy
cutino
|
100 boston scientific way |
marlborough, MA 01752
|
5086834000
|
|
MDR Report Key | 5250060 |
MDR Text Key | 32116382 |
Report Number | 3005099803-2015-03402 |
Device Sequence Number | 1 |
Product Code |
PGT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K141848 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/06/2015 |
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 | 06/01/2016 |
Device Model Number | FG-0202 |
Device Lot Number | 0044754051 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/06/2015
|
Initial Date FDA Received | 11/25/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/13/2015 |
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 |