Brand Name | FIBERSCOPE "CYF-5", EUROPEAN VERSION |
Manufacturer (Section D) |
OLYMPUS TOKIO |
shinjuku monolith, 2-3-1 nishi-shinjuku, shinjuku-ku |
tokio, hamburg 163-0 914 |
JA 163-0914 |
|
Manufacturer Contact |
katsuaki
morita
|
2951 ishikawa-cho |
hachioji-shi, tokyo-to 192-8-507
|
JA
192-8507
|
426425177
|
|
MDR Report Key | 7032045 |
MDR Text Key | 93437133 |
Report Number | 8010047-2017-01785 |
Device Sequence Number | 1 |
Product Code |
FAJ
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
12/22/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | CYF-5 |
Other Device ID Number | 04042761051453 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/18/2017
|
Initial Date FDA Received | 11/15/2017 |
Supplement Dates Manufacturer Received | 11/23/2017
|
Supplement Dates FDA Received | 12/21/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/09/2009 |
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 |
|
|