Brand Name | DA VINCI XI MONOPOLAR CURVED SCISSOR |
Type of Device | SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT |
Manufacturer (Section D) |
INTUITIVE SURGICAL, INC. |
sunnyvale CA 94086 |
|
MDR Report Key | 7788848 |
MDR Text Key | 117448917 |
Report Number | MW5079167 |
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 |
08/14/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/15/2018 |
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 | 470179 |
Device Lot Number | N10180621 0110 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/14/2018 |
Is the Reporter a Health Professional? |
Yes
|
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 |
Patient Age | 59 YR |
Patient Weight | 87 |
|
|