Brand Name | LUMENIS MOSES 200 D\F\L |
Type of Device | POWERED LASER SURGICAL INSTRUMENT |
Manufacturer (Section D) |
LUMENIS LTD |
hakidma 6 |
yokneam 20692 04 |
IS 2069204 |
|
Manufacturer (Section G) |
ADVANCED FIBER TOOLS GMBH |
bornheimer str 4 |
|
mittweida 09468 |
GM
09468
|
|
Manufacturer Contact |
farshad
fahimi
|
4100 hamline avenue north |
building c |
saint paul, MN 55112
|
|
MDR Report Key | 18744753 |
MDR Text Key | 336764613 |
Report Number | 2124215-2024-10173 |
Device Sequence Number | 1 |
Product Code |
GEX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K170121 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/20/2024 |
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 | 1912-10 |
Device Catalogue Number | 1912-10 |
Device Lot Number | 0001912306 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/15/2024
|
Initial Date FDA Received | 02/20/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/27/2023 |
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 |