Brand Name | SPYSCOPE DS ACCESS & DELIVERY CATHETER |
Type of Device | CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - SPENCER |
780 brookside drive |
spencer IN 47460 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC - SPENCER |
780 brookside drive |
|
spencer IN 47460 |
|
Manufacturer Contact |
nancy
cutino
|
100 boston scientific way |
marlborough, MA 01752
|
5086834000
|
|
MDR Report Key | 6739463 |
MDR Text Key | 80869754 |
Report Number | 3005099803-2017-02169 |
Device Sequence Number | 1 |
Product Code |
FBN
|
UDI-Device Identifier | 08714729863236 |
UDI-Public | (01)08714729863236(17)20181031(10)19821327 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K142922 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
06/27/2017 |
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 |
Medical Equipment Company Technician/Representative
|
Device Expiration Date | 10/31/2018 |
Device Model Number | M00546600 |
Device Catalogue Number | 4660 |
Device Lot Number | 19821327 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/14/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/27/2017
|
Initial Date FDA Received | 07/25/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/10/2016 |
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 |