Brand Name | SINGLE USE 3-LUMEN SPHINCTEROTOME V |
Type of Device | SINGLE USE 2-LUMEN SPHINCTEROTOME |
Manufacturer (Section D) |
AOMORI OLYMPUS CO., LTD. |
2-248-1 okkonoki |
kuroishi-shi, aomori 036-0 357 |
JA 036-0357 |
|
Manufacturer (Section G) |
AOMORI OLYMPUS CO., LTD. |
2-248-1 okkonoki |
|
kuroishi-shi, aomori 036-0 357 |
JA
036-0357
|
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 19182489 |
MDR Text Key | 341500845 |
Report Number | 9614641-2024-00985 |
Device Sequence Number | 1 |
Product Code |
KNS
|
UDI-Device Identifier | 04953170184031 |
UDI-Public | 04953170184031 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K950166 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/25/2024 |
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 | KD-V411M-0725 |
Device Lot Number | 37K |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/02/2024 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/12/2024
|
Initial Date FDA Received | 04/25/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Treatment | CV-290 CLV-290SL JF-260V |
|
|