Brand Name | GREENLIGHT MOXY FIBER OPTIC |
Type of Device | POWERED LASER SURGICAL INSTRUMENT |
Manufacturer (Section D) |
AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) |
3070 orchard drive |
san jose CA 95134 |
|
Manufacturer (Section G) |
AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) |
3070 orchard drive |
|
san jose CA 95134 |
|
Manufacturer Contact |
alyson
harris
|
3070 orchard drive |
san jose, CA 95134
|
4084563300
|
|
MDR Report Key | 8019062 |
MDR Text Key | 125473957 |
Report Number | 2937094-2018-01074 |
Device Sequence Number | 1 |
Product Code |
GEX
|
UDI-Device Identifier | 00878953005515 |
UDI-Public | 00878953005515 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/16/2018 |
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 Expiration Date | 05/03/2020 |
Device Model Number | 0010-2400 |
Device Catalogue Number | 0010-2400 |
Device Lot Number | 22075868 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/16/2018 |
Initial Date Manufacturer Received |
10/29/2018 |
Initial Date FDA Received | 10/30/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/03/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |