Brand Name | LITHO EVO |
Type of Device | SURGICAL LASER |
Manufacturer (Section D) |
QUANTA SYSTEM S.P.A. |
via acquedotto, 109 |
samarate, 21017 |
IT 21017 |
|
Manufacturer (Section G) |
QUANTA SYSTEM S.P.A. |
via acquedotto, 109 |
|
samarate, 21017 |
IT
21017
|
|
Manufacturer Contact |
francesco
dell'antonio
|
via acquedotto, 109 |
samarate, varese 21017
|
IT
21017
|
|
MDR Report Key | 11829868 |
MDR Text Key | 250799446 |
Report Number | 3004378299-2021-00080 |
Device Sequence Number | 1 |
Product Code |
GEX
|
Combination Product (y/n) | N |
Reporter Country Code | MY |
PMA/PMN Number | K192990 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Remedial Action |
Inspection |
Type of Report
| Initial |
Report Date |
05/15/2021 |
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 |
No Information
|
Device Model Number | PVMS00058 |
Initial Date Manufacturer Received |
04/16/2021
|
Initial Date FDA Received | 05/15/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 09/30/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|