Brand Name | DA VINCI FORCEPS |
Type of Device | SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT |
Manufacturer (Section D) |
INTUITIVE SURGICAL, INC. |
1266 kifer rd |
sunnyvale CA 94086 |
|
MDR Report Key | 6857773 |
MDR Text Key | 85802829 |
Report Number | 6857773 |
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 |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
08/28/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/12/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Lot Number | N10170612 |
Other Device ID Number | 028773 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/28/2017 |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/28/2017 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Treatment | NO |
|
|