Brand Name | SINGLE USE MECHANICAL LITHOTRIPTOR V |
Type of Device | SINGLE USE MECHANICAL LITHOTRIPTOR |
Manufacturer (Section D) |
AOMORI OLYMPUS CO., LTD. |
2-248-1 okkonoki |
kuroishi-shi, aomori 036-0 357 |
JA 036-0357 |
|
Manufacturer (Section G) |
AOMORI OLYMPUS CO., LTD. |
2-248-1 okkonoki |
|
kuroishi-shi, aomori |
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 15925221 |
MDR Text Key | 304907187 |
Report Number | 9614641-2022-00709 |
Device Sequence Number | 1 |
Product Code |
LQC
|
UDI-Device Identifier | 14953170218399 |
UDI-Public | 04953170218392 |
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | CLASS2-EXMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Study,Literature,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
12/19/2022 |
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 | BML-V242QR-30 |
Device Lot Number | UNKNOWN(LITERATURE) |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/06/2022
|
Initial Date FDA Received | 12/06/2022 |
Supplement Dates Manufacturer Received | 12/06/2022 12/08/2022
|
Supplement Dates FDA Received | 12/06/2022 12/19/2022
|
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 |
Treatment | NON-OLYMPUS, AURIGA, HOLMIUM LASER, SN UNKNOWN; NON-OLYMPUS, CRE, SN UNKNOWN; NON-OLYMPUS, EXTRACTOR PRO XL, SN UNKNOWN; NON-OLYMPUS, SPYSCOPE DS,, SN UNKNOWN; NON-OLYMPUS, ULTRATOME XL, SN UNKNOWN; NON-OLYMPUS, VISIGLIDE, SN UNKNOWN; OLYMPUS FG-V425PR, SN UNKNOWN; OLYMPUS TJF-Q180V, SN UNKNOWN |
Patient Outcome(s) |
Other;
Required Intervention;
|
|
|