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Intuitive Surgical, Inc. recalls STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler
Recalled August 17, 2016 · FDA recall Z-2349-2016 · Intuitive Surgical
Hazard
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 Class II
Units
2065 total
Sold at
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.
Description
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
Product
STAPLER 30, IS4000, model number 470430; 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.
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →