Brand Name | SINGLE USE ELECTROSURGICAL SNARE SD-400 |
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 Contact |
masaharu
hirose
|
2-248-1 okkonoki |
kuroishi-shi, aomori 036-0-357
|
JA
036-0357
|
426422891
|
|
MDR Report Key | 15491384 |
MDR Text Key | 300702283 |
Report Number | 9614641-2022-00368 |
Device Sequence Number | 1 |
Product Code |
FDI
|
UDI-Device Identifier | 04953170396694 |
UDI-Public | 04953170396694 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K172734 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Study,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
11/28/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/27/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | SD-400U-10 |
Device Lot Number | UNKNOWN(LITERATURE) |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 11/02/2022 |
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 |
Initial
|
Patient Sequence Number | 1 |
Treatment | NON-OLYMPUS, ENDOSCOPES; OLYMPUS, CF-HQ290I |
Patient Outcome(s) |
Required Intervention;
Other;
|
|
|