Home / Recalls / Intuitive Surgical, Inc. / Z-1726-2017

Z-1726-2017 Class II Terminated

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

FDA device recall Z-1726-2017 was initiated by Intuitive Surgical, Inc. on March 15, 2017 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated December 10, 2018). Affected quantity: 2059 shipped - all languages.

Recall Details

Product Type: Devices
Report Date: April 12, 2017
Initiation Date: March 15, 2017
Termination Date: December 10, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2059 shipped - all languages

Product Description

STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Portuguese 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).

Reason for Recall

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.

Distribution Pattern

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, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Venezuela

Code Information

Part number: 381395-01

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