Brand Name | VESSEL SEALER |
Type of Device | SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT |
Manufacturer (Section D) |
INTUITIVE SURGICAL, INC. |
1266 kifer rd |
building 101 |
sunnyvale CA 94086 5304 |
|
MDR Report Key | 7769149 |
MDR Text Key | 116798945 |
Report Number | MW5078988 |
Device Sequence Number | 2 |
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 |
Risk Manager
|
Type of Report
| Initial |
Report Date |
08/01/2018 |
2 Devices were Involved in the Event: |
1
2
|
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 Lot Number | M10611124 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/08/2018 |
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 | 68 YR |
|
|