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.
This recall has been terminated (originally issued August 5, 2016).
- Company
- Intuitive Surgical, Inc.
- Recall Initiated
- July 14, 2016
- Posted
- August 5, 2016
- Terminated
- January 3, 2017
- Recall Number
- Z-2350-2016
- Quantity
- 2065 total
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
All
Root 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.