Recall Z-2350-2016
Intuitive Surgical, Inc. · initiated July 14, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
Codes / lots: All
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
FDA-determined cause: Software design
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.
Details
- Recall number
- Z-2350-2016
- Initiated
- July 14, 2016
- Posted by FDA
- August 5, 2016
- Terminated
- January 3, 2017
- Product code
- NAY – System, Surgical, Computer Controlled Instrument
- Quantity
- 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, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.
- Recalling firm
- Intuitive Surgical, Inc., Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2348-2016 Class II | STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical…An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler… | 07/14/2016Terminated |
| Z-2349-2016 Class II | STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive…An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler… | 07/14/2016Terminated |