CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist S
FDA device recall Z-2350-2016 · posted 2016-08-05 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
- Action taken
- Field Safety Notifications - Urgent Medical Device Corrections and Removal letters were sent on July 15, 2016 (dated July 14, 2016 advised users of the Stapler Firing Failed message and actions to take should the message be received.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 2065 total
- Distribution
- US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, ,
- Date initiated
- 2016-07-14
- Date posted
- 2016-08-05
- Date terminated
- 2017-01-03
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IS4000 Stapler 30 Instrument and Stapler 30 Reloads (K152421) | Intuitive Surgical, Inc. | 2016-03-04 |