MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-08 for INTUITIVE SURGICAL LARGE NEEDLE DRIVER manufactured by Intuitive Surgical.
[35746615]
Davinci large needle driver was unable to hold (properly grasp) suture needles. Suture needle would slip out from teeth of needle driver when trying to place suture needle in needle driver. Defective instrument removed from field and replaced. No obvious injury to pt. No obvious broken, loose or fragmented wires present on defective instrument. Event abated after use: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059231 |
| MDR Report Key | 5360868 |
| Date Received | 2016-01-08 |
| Date of Report | 2015-10-21 |
| Date of Event | 2015-10-20 |
| Date Added to Maude | 2016-01-12 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | INTUITIVE SURGICAL LARGE NEEDLE DRIVER |
| Generic Name | LARGE NEEDLE DRIVER |
| Product Code | GFC |
| Date Received | 2016-01-08 |
| Lot Number | N10150210212 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-01-08 |