Brand Name | SHOCKPULSE SE LITHOTRIPSY PROBE, REUSABLE, 3.76MM |
Type of Device | ELECTROHYDRAULIC LITHOTRIPTOR. |
Manufacturer (Section D) |
CYBERSONICS INC. |
5340 fryling road |
suite 101 |
erie PA 16510 4703 |
|
Manufacturer (Section G) |
CYBERSONICS INC. |
5340 fryling road |
suite 101 |
erie PA 16510 4703 |
|
Manufacturer Contact |
samradni
patil
|
5340 fryling road |
suite 101 |
erie, PA 16510-4703
|
8149201510
|
|
MDR Report Key | 8015434 |
MDR Text Key | 125456662 |
Report Number | 3004216443-2018-00003 |
Device Sequence Number | 1 |
Product Code |
FEO
|
UDI-Device Identifier | 00855279005177 |
UDI-Public | (01)00855279005177(11)161114(10)W1606049 |
Combination Product (y/n) | N |
PMA/PMN Number | K171024 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Type of Report
| Initial |
Report Date |
10/30/2018 |
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 | SPL-PR376 |
Device Lot Number | W1605950 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/16/2018 |
Initial Date FDA Received | 10/29/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/14/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |