Brand Name | LITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE |
Type of Device | URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - MARLBOROUGH |
100 boston scientific way |
marlborough MA 01752 |
|
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 | 6740301 |
MDR Text Key | 80930874 |
Report Number | 3005099803-2017-02222 |
Device Sequence Number | 1 |
Product Code |
FGB
|
UDI-Device Identifier | 08714729874805 |
UDI-Public | (01)08714729874805(17)20190602(10)20723730 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K153049 |
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 |
07/11/2017 |
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 |
Health Professional
|
Device Expiration Date | 06/02/2019 |
Device Model Number | M0067913500 |
Device Catalogue Number | 791-350 |
Device Lot Number | 20723730 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/11/2017 |
Initial Date FDA Received | 07/25/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/08/2017 |
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 |