Brand Name | FORCEPS/IRRIGATION PLUG (ISOLATED TYPE) |
Type of Device | FORCEPS/ IRRIGATION PLUG |
Manufacturer (Section D) |
AIZU OLYMPUS CO., LTD. |
3-1-1 niiderakita |
aizuwakamatsu-shi, fukushima 965-8 520 |
JA 965-8520 |
|
Manufacturer Contact |
masaharu
hirose
|
3-1-1 niiderakita |
aizuwakamatsu-shi, fukushima 965-8-520
|
JA
965-8520
|
426422891
|
|
MDR Report Key | 15363453 |
MDR Text Key | 305873647 |
Report Number | 9610595-2022-01562 |
Device Sequence Number | 1 |
Product Code |
FGB
|
UDI-Device Identifier | 04953170063114 |
UDI-Public | 04953170063114 |
Combination Product (y/n) | N |
Reporter Country Code | SP |
PMA/PMN Number | K912120 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
09/06/2022 |
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 | MAJ-891 |
Device Lot Number | 1YA |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/02/2022 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/24/2022 |
Initial Date FDA Received | 09/06/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/18/2021 |
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 |
|
|