Brand Name | DISPOSABLE DISTAL ATTACHMENT |
Type of Device | DISPOSABLE DISTAL ATTACHMENT |
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 |
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 18515022 |
MDR Text Key | 332902000 |
Report Number | 9614641-2024-00084 |
Device Sequence Number | 1 |
Product Code |
FDS
|
UDI-Device Identifier | 04953170278280 |
UDI-Public | 04953170278280 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K984358 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Study,Literature,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/07/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | D-201-11804 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/18/2023
|
Initial Date FDA Received | 01/15/2024 |
Supplement Dates Manufacturer Received | 03/05/2024
|
Supplement Dates FDA Received | 03/07/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | CLIP (HX-610-090); ELECTROSURGICAL HEMOSTATIC FORCEPS (FD-410LR); GASTROINTESTINAL VIDEOSCOPE (GIF-Q260J); ROTATABLE CLIP FIXING DEVICE (HX-110LR); SINGLE USE ELECTROSURGICAL KNIFE (KD-611L) |
Patient Outcome(s) |
Required Intervention;
|
|
|