MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for ENDOWRIST manufactured by Intuitive Surgical, Inc..
[185025016]
The surgeon was ready to fire the robot stapler 30 curved with a vascular load and when it fired it made a grinding sound that it had not previously made. The staple line was intact, and the area was assessed and did not seem to be abnormal. The stapler was removed from the field and the manager was notified. The manager stated that he will have the stapler sent out to be assessed. The stapler was bagged and labeled to be cleaned and returned to manager.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882506 |
| MDR Report Key | 9882506 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-09 |
| Report Date | 2020-03-13 |
| Date Reported to FDA | 2020-03-13 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOWRIST |
| Generic Name | SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT |
| Product Code | NAY |
| Date Received | 2020-03-26 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL, INC. |
| Manufacturer Address | 1266 KIFER ROAD SUNNYVALE CA 94086 US 94086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |