Brand Name | TX1 TISSUE REMOVAL SYSTEM - MICROTIP |
Type of Device | ULTRASONIC SURGICAL ASPIRATOR |
Manufacturer (Section D) |
TENEX HEALTH |
lake forest CA |
|
Manufacturer Contact |
|
26902 vista terrace |
lake forest, CA 92630
|
9494547500
|
|
MDR Report Key | 3902908 |
MDR Text Key | 4426740 |
Report Number | 2085033-2014-00535 |
Device Sequence Number | 1 |
Product Code |
LFL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123640 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/14/2014 |
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 Catalogue Number | 554-1003-001 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/20/2014
|
Initial Date FDA Received | 02/24/2014 |
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 |