Brand Name | ELECTROSURGICAL SNARE |
Type of Device | ELECTROSURGICAL SNARE |
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 | 18369383 |
MDR Text Key | 331048022 |
Report Number | 9614641-2023-01962 |
Device Sequence Number | 1 |
Product Code |
FAS
|
UDI-Device Identifier | 04953170035951 |
UDI-Public | 04953170035951 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K955650 |
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 |
02/02/2024 |
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 | SD-7P-1 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 12/20/2023 |
Supplement Dates Manufacturer Received | 01/31/2024
|
Supplement Dates FDA Received | 02/02/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|