Brand Name | EXABLATE 4000 |
Type of Device | MR GUIDED FOCUSED ULTRASOUND SYSTEM |
Manufacturer (Section D) |
INSIGHTEC LTD. |
5 nahum heth street |
tirat carmel, 39120 |
IS 39120 |
|
Manufacturer (Section G) |
INSIGHTEC LTD. |
5 nachum heth |
|
tirat carmel, 39120 |
IS
39120
|
|
Manufacturer Contact |
lena
taratetsky
|
5 nachum heth |
tirat carmel, 39120
|
IS
39120
|
|
MDR Report Key | 16483732 |
MDR Text Key | 310677822 |
Report Number | 9615058-2023-00007 |
Device Sequence Number | 1 |
Product Code |
POH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P150038 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/05/2023 |
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 Model Number | 4000 |
Device Catalogue Number | SYS942001 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/03/2023
|
Initial Date FDA Received | 03/06/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Disability;
|