Brand Name | VASOVIEW 7 XB BISECTOR (OUS) |
Type of Device | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Manufacturer (Section D) |
MAQUET CARDIOVASCULAR LLC |
45 barbour pond drive |
wayne NJ |
|
Manufacturer (Section G) |
MAQUET CARDIOVASCULAR LLC |
45 barbour pond drive |
|
wayne NJ |
|
Manufacturer Contact |
arelean
guzman
|
45 barbour pond drive |
wayne, NJ
|
|
MDR Report Key | 15933194 |
MDR Text Key | 307991287 |
Report Number | 2242352-2022-01003 |
Device Sequence Number | 1 |
Product Code |
GEI
|
UDI-Device Identifier | 00607567700437 |
UDI-Public | 00607567700437 |
Combination Product (y/n) | N |
Reporter Country Code | SN |
PMA/PMN Number | K041981 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Nurse Practitioner
|
Type of Report
| Initial,Followup,Followup |
Report Date |
01/11/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/07/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/17/2024 |
Device Model Number | VASOVIEW 7 XB BISECTOR (OUS) |
Device Catalogue Number | VH-3200-W |
Device Lot Number | 25163305 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/28/2022 |
Date Manufacturer Received | 01/13/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/18/2022 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | STORZ AUTOCON II 200 ESU. |