Brand Name | ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE |
Type of Device | FLEX 3D DEFLECTABLE VIDEOSCOPE |
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 | 18937245 |
MDR Text Key | 338116276 |
Report Number | 9610595-2024-05852 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
UDI-Device Identifier | 04953170340710 |
UDI-Public | 04953170340710 |
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | K123365 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/19/2024 |
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 |
Other
|
Device Model Number | LTF-190-10-3D |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/08/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/09/2020 |
Initial Date FDA Received | 03/19/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/23/2018 |
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 |