Brand Name | OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V |
Type of Device | LITHOTRIPTOR |
Manufacturer (Section D) |
OLYMPUS MEDICAL SYSTEM CORP. |
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 | 3784930 |
MDR Text Key | 4438565 |
Report Number | 2951238-2014-00050 |
Device Sequence Number | 1 |
Product Code |
FEO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K903529 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
01/22/2014 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | BML-V442QR-30 |
Device Catalogue Number | BML-V442QR-30 |
Device Lot Number | 3YK |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/22/2014
|
Initial Date FDA Received | 02/07/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |