Brand Name | EVIS EXERA II VIDEO SYSTEM CENTER |
Type of Device | VIDEO SYSTEM CENTER |
Manufacturer (Section D) |
OLYMPUS MEDICAL SYSTEMS CORP. |
2951 ishikawa-cho |
hachioji-shi, tokyo-to 192-8 507 |
JA
192-8507
|
|
Manufacturer Contact |
kazutaka
matsumoto
|
2951 ishikawa-cho |
hachioji-shi, tokyo-to 192-8-507
|
JA
192-8507
|
426425177
|
|
MDR Report Key | 10858982 |
MDR Text Key | 225930584 |
Report Number | 8010047-2020-09079 |
Device Sequence Number | 1 |
Product Code |
FAJ
|
Combination Product (Y/N) | N |
Reporter Country Code | AS |
PMA/PMN Number | K133538 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
FOREIGN,HEALTH PROFESSIONAL,U |
Reporter Occupation |
BIOMEDICAL ENGINEER
|
Type of Report
| Initial,Followup |
Report Date |
01/08/2021 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 11/18/2020 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | CV-180 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 10/20/2020 |
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 12/25/2020 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 06/09/2010 |
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unkown
|
|
|