Intuitive Surgical, Inc. recalls STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi French SRK General an…

Recall date

March 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1719-2017

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Luxembourg, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Singapore, South Korea, Spain, S…

Why it was recalled

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi French SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories 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 can be used with staple line or tissue butressing material (natural or synthetic).