Brand Name | ENDOWRIST SMALL GRASPING RETRACTOR |
Type of Device | SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT |
Manufacturer (Section D) |
INTUITIVE SURGICAL, INC. |
1266 kifer road |
sunnyvale CA 94086 |
|
MDR Report Key | 12736798 |
MDR Text Key | 279622171 |
Report Number | 12736798 |
Device Sequence Number | 1 |
Product Code |
NAY
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Type of Report
| Initial |
Report Date |
10/28/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/02/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 470318 |
Device Lot Number | N102011300134 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/27/2021 |
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/28/2021 |
Device Age | 1 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/02/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|