Brand Name | EVIS LUCERA DUODENOVIDEOSCOPE |
Type of Device | DUODENOVIDEOSCOPE |
Manufacturer (Section D) |
AIZU OLYMPUS CO., LTD. |
3-1-1 niiderakita |
aizuwakamatsu-shi, fukushima 965-8 520 |
JA 965-8520 |
|
Manufacturer (Section G) |
AIZU OLYMPUS CO., LTD. |
3-1-1 niiderakita |
|
aizuwakamatsu-shi, fukushima 965-8 520 |
JA
965-8520
|
|
Manufacturer Contact |
kazutaka
matsumoto
|
2951 ishikawa-cho |
hachioji-shi, tokyo-to 192-8-507
|
JA
192-8507
|
426425177
|
|
MDR Report Key | 13350360 |
MDR Text Key | 294784048 |
Report Number | 8010047-2022-01973 |
Device Sequence Number | 1 |
Product Code |
FDT
|
Combination Product (y/n) | N |
Reporter Country Code | KS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
05/08/2024 |
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 | TJF-260V |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/02/2022 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/02/2022
|
Initial Date FDA Received | 01/25/2022 |
Supplement Dates Manufacturer Received | 02/08/2022 01/03/2022 05/08/2024
|
Supplement Dates FDA Received | 03/03/2022 04/18/2023 05/08/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/26/2008 |
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 |