Brand Name | URETEROSCOPE 6.7/8.4 FR. X 330 MM, 5°, STRAIGHT OCULAR, 4.2 FR. CHANNEL |
Type of Device | RIGID URETEROSCOPE |
Manufacturer (Section D) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
hamburg, de 22045 |
GM 22045 |
|
Manufacturer (Section G) |
OLYMPUS WINTER & IBE GMBH |
kuehnstra¿¿e 61 |
|
hamburg, de |
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 16519286 |
MDR Text Key | 311492401 |
Report Number | 9610773-2023-00712 |
Device Sequence Number | 1 |
Product Code |
FGB
|
UDI-Device Identifier | 04042761086394 |
UDI-Public | 04042761086394 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K200369 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial,Followup |
Report Date |
06/19/2023 |
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 Model Number | WA2UR12A |
Device Catalogue Number | WA2UR12A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/27/2023 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/06/2023
|
Initial Date FDA Received | 03/09/2023 |
Supplement Dates Manufacturer Received | 06/02/2023
|
Supplement Dates FDA Received | 06/19/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/10/2022 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|