Brand Name | EVIS EXERA LLL COLONOVIDEOSCOPE |
Type of Device | COLONOVIDEOSCOPE |
Manufacturer (Section D) |
OLYMPUS MEDICAL SYSTEMS CORP. |
2951 ishikawa-cho |
hachioji-shi, tokyo-to |
|
Manufacturer Contact |
connie
tubera
|
2400 ringwood avenue |
san jose, CA 95131
|
4089355124
|
|
MDR Report Key | 8143728 |
MDR Text Key | 129754438 |
Report Number | 2951238-2018-00748 |
Device Sequence Number | 1 |
Product Code |
FDF
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K112680 |
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,Followup |
Report Date |
02/14/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/07/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | PCF-H190L |
Device Catalogue Number | PCF-H190L |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/07/2018 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 01/22/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Treatment Data |
Date Received: 12/07/2018 Patient Sequence Number: 1 |
|
|