Brand Name | OLYMPUS ULTRASONIC LITHOTRIPTOR PROBE |
Type of Device | LITHOTRIPTOR PROBE |
Manufacturer (Section D) |
OLYMPUS MEDICAL SYSTEM CORPORATION |
2951 ishikawa-cho, hachioji-shi |
tokyo 192- 8507 |
JA 192-8507 |
|
Manufacturer (Section G) |
OLYMPUS MEDICAL SYSTEM CORPORATION |
2951 ishikawa-cho, hachioji-shi |
|
tokyo 192- 8507 |
JA
192-8507
|
|
Manufacturer Contact |
noemi
schambach
|
2400 ringwood ave. |
san jose, CA 95131
|
4089355002
|
|
MDR Report Key | 3896050 |
MDR Text Key | 4542472 |
Report Number | 2951238-2014-00202 |
Device Sequence Number | 1 |
Product Code |
FEO
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
05/06/2014 |
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 | MAJ-985 |
Device Catalogue Number | MAJ-985 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/06/2014
|
Initial Date FDA Received | 05/20/2014 |
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 |
|
|