Brand Name | EUS EXERA ULTRASONIC GASTROVIDEOSCOPE |
Type of Device | ULTRASONIC GASTROVIDEOSCOPE |
Manufacturer (Section D) |
SHIRAKAWA OLYMPUS CO., LTD. |
3-1 okamiyama |
odakura, nishigo-mura, |
nishishirakawa-gun, fukushima 961-8 061 |
JA 961-8061 |
|
Manufacturer Contact |
masaharu
hirose
|
3-1 okamiyama |
odakura, nishigo-mura, |
nishishirakawa-gun, fukushima 961-8-061
|
JA
961-8061
|
426422891
|
|
MDR Report Key | 15674610 |
MDR Text Key | 302430915 |
Report Number | 3002808148-2022-03554 |
Device Sequence Number | 1 |
Product Code |
ODG
|
Combination Product (y/n) | N |
Reporter Country Code | SZ |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Study,Literature,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
01/23/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | GF-UCT160-OL5 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/28/2022
|
Initial Date FDA Received | 10/26/2022 |
Supplement Dates Manufacturer Received | 01/16/2023
|
Supplement Dates FDA Received | 01/23/2023
|
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
|
Patient Sequence Number | 1 |
Treatment | UNKNOWN, EUSRA RF ELECTRODE |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 58 YR |
Patient Sex | Male |
|
|