Brand Name | SLIMLINE SIS EZ |
Type of Device | POWERED LASER SURGICAL INSTRUMENT |
Manufacturer (Section D) |
LUMENIS LTD |
hakidma 6 |
yokneam 20692 04 |
IS 2069204 |
|
Manufacturer (Section G) |
MOLEX LLC |
18019 n 25th ave |
|
phoenix AZ 85023 |
|
Manufacturer Contact |
farshad
fahimi
|
4100 hamline avenue north |
building c |
saint paul, MN 55112
|
|
MDR Report Key | 19197447 |
MDR Text Key | 341464203 |
Report Number | 2124215-2024-25233 |
Device Sequence Number | 1 |
Product Code |
GEX
|
UDI-Device Identifier | 17290109145669 |
UDI-Public | 17290109145669 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K170121 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/26/2024 |
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 | 0644-020-01 |
Device Catalogue Number | 0644-020-01 |
Device Lot Number | 0011350623 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/11/2024
|
Initial Date FDA Received | 04/26/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/02/2023 |
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 |