Brand Name | DA VINCI LARGE SUTURECUT NEEDLE DRIVER |
Type of Device | SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT |
Manufacturer (Section D) |
INTUITIVE SURGICAL, INC. |
sunnyvale CA 94086 |
|
MDR Report Key | 13087456 |
MDR Text Key | 282898178 |
Report Number | MW5106268 |
Device Sequence Number | 1 |
Product Code |
NAY
|
Combination Product (y/n) | N |
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 |
12/21/2021 |
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 | XI |
Device Catalogue Number | 471296 VER 07 |
Device Lot Number | N11211011 0105 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/21/2021 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/23/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|