Brand Name | ULTRASONIC PROBE |
Type of Device | ULTRASONIC PROBE |
Manufacturer (Section D) |
SHIRAKAWA OLYMPUS CO., LTD. |
3-1 okamiyama, |
odakura, nishigo-mura |
nishishirakawa-gun, fukushima 961-8 061 |
JA 961-8061 |
|
Manufacturer (Section G) |
SHIRAKAWA OLYMPUS CO., LTD. |
3-1 okamiyama, |
odakura, nishigo-mura |
nishishirakawa-gun, fukushima 961-8 061 |
JA
961-8061
|
|
Manufacturer Contact |
kazutaka
matsumoto
|
2951 ishikawa-cho |
hachioji-shi, tokyo-to 192-8-507
|
JA
192-8507
|
426425177
|
|
MDR Report Key | 13014805 |
MDR Text Key | 286052116 |
Report Number | 8010047-2021-16209 |
Device Sequence Number | 1 |
Product Code |
ITX
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K982323 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Distributor |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup,Followup |
Report Date |
05/08/2024 |
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 | UM-S20-17S |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/01/2021
|
Initial Date FDA Received | 12/15/2021 |
Supplement Dates Manufacturer Received | 12/15/2023 05/08/2024
|
Supplement Dates FDA Received | 12/15/2023 05/08/2024
|
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 |
|
|