Brand Name | VERSACUT |
Type of Device | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
Manufacturer (Section D) |
LUMENIS LTD |
hakidma 6 |
yokneam 20692 04 |
IS 2069204 |
|
Manufacturer (Section G) |
LUMENIS LTD. |
hakidma st 6 |
|
yokneam 20692 04 |
IS
2069204
|
|
Manufacturer Contact |
alyson
harris
|
4100 hamline avenue north |
building c |
saint paul, MN 55112
|
|
MDR Report Key | 16544087 |
MDR Text Key | 311288456 |
Report Number | 2124215-2023-11617 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
UDI-Device Identifier | 07290109140681 |
UDI-Public | 07290109140681 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/15/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 0637-245-01 |
Device Catalogue Number | 0637-245-01 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/03/2023 |
Initial Date FDA Received | 03/15/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/23/2014 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|