Brand Name | SHOCKPULSE LITHOTRIPSY TRANSDUCER. |
Type of Device | LITHOTRIPTOR, ULTRASONIC |
Manufacturer (Section D) |
GYRUS ACMI, INC. |
9600 louisiana avenue north |
brooklyn park MN 55445 |
|
Manufacturer (Section G) |
GYRUS ACMI, INC. |
9600 louisiana avenue north |
|
brooklyn park MN 55445 |
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 19065619 |
MDR Text Key | 340461000 |
Report Number | 3011050570-2024-10059 |
Device Sequence Number | 1 |
Product Code |
FEO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K142428 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/08/2024 |
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-T |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/15/2024 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/13/2024
|
Initial Date FDA Received | 04/08/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/14/2019 |
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 |