Brand Name | LITHOVUE SYSTEM WORKSTATION |
Type of Device | URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
4100 hamline avenue |
attn: return products |
st. paul MN 55112 |
|
Manufacturer Contact |
carole
morley
|
300 boston scientific way |
marlborough, MA 01752
|
5086834015
|
|
MDR Report Key | 12077039 |
MDR Text Key | 258705411 |
Report Number | 3005099803-2021-03071 |
Device Sequence Number | 1 |
Product Code |
FGB
|
UDI-Device Identifier | 08714729974789 |
UDI-Public | 08714729974789 |
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 |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
09/14/2021 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 06/28/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | 801-000 |
Device Catalogue Number | 801-000 |
Device Lot Number | LV03342 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/11/2021 |
Is the Reporter a Health Professional? |
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 08/25/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/28/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
|
Type of Device Usage |
Unkown
|