Brand Name | FIBERSCOPE, "CYF-5", UK VERSION |
Type of Device | CYSTONEPHROFIBERSCOPE |
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 | 10361742 |
MDR Text Key | 202609061 |
Report Number | 8010047-2020-05254 |
Device Sequence Number | 1 |
Product Code |
FAJ
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
PMA/PMN Number | K032092 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
USER FACILITY |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
10/01/2020 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 08/04/2020 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | CYF-5 |
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 | 09/07/2020 |
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
|
|
|