Brand Name | DA VINCI MEGA SUTURECUT NEEDLE DRIVER |
Type of Device | SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT |
Manufacturer (Section D) |
INTUITIVE SURGICAL, INC. |
sunnyvale CA 94086 |
|
MDR Report Key | 10829074 |
MDR Text Key | 216147015 |
Report Number | MW5097786 |
Device Sequence Number | 1 |
Product Code |
NAY
|
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
11/07/2020 |
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 | DA VINCI XI |
Device Catalogue Number | 470309 VER 14 |
Device Lot Number | N12191028 0045 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/07/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 11/10/2020 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|