Brand Name | EVIS EXERA II 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 |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 15871457 |
MDR Text Key | 307888143 |
Report Number | 9610595-2022-04557 |
Device Sequence Number | 1 |
Product Code |
FDT
|
UDI-Device Identifier | 04953170339967 |
UDI-Public | 04953170339967 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K143153 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Biomedical Engineer
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
11/28/2022 |
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-Q180V |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/28/2021 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/28/2021
|
Initial Date FDA Received | 11/28/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/26/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | Z-0379-2022 |
Patient Sequence Number | 1 |
|
|