Brand Name | VISUALASE |
Type of Device | POWERED LASER SURGICAL INSTRUMENT |
Manufacturer (Section D) |
MEDTRONIC NAVIGATION, INC |
826 coal creek circle |
louisville CO 80027 |
|
Manufacturer (Section G) |
MEDTRONIC NAVIGATION, INC |
826 coal creek circle |
|
louisville CO 80027 |
|
Manufacturer Contact |
david
gustafson
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635149628
|
|
MDR Report Key | 12280285 |
MDR Text Key | 265151379 |
Report Number | 1723170-2021-01999 |
Device Sequence Number | 1 |
Product Code |
GEX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K053087 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/05/2021 |
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 |
Health Professional
|
Device Model Number | 9735560 |
Device Catalogue Number | 9735560 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/23/2021 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/15/2021
|
Initial Date FDA Received | 08/05/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
Patient Age | 38 YR |
Patient Weight | 86 |