Brand Name | URETERO-RENO VIDEOSCOPE |
Type of Device | URETERO-RENO VIDEOSCOPE |
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 | 8868558 |
MDR Text Key | 216960207 |
Report Number | 8010047-2019-02878 |
Device Sequence Number | 1 |
Product Code |
FGB
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K072957 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
|
Type of Report
| Initial,Followup,Followup |
Report Date |
11/17/2019 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 08/07/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | URF-V |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 10/28/2019 |
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
|
|
|