Intuitive Surgical, Inc.: STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Danish 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).

Recall number

Z-1715-2017

Recalling firm

Intuitive Surgical, Inc.

Product

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

Status

Terminated

Initiated

2017-03-15

Posted

not on file

Terminated

2018-12-10

Reason

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.

Root cause

Device Design

Action

Intuitive sent an Urgent Medical Device Correction (ISIFA2017-02-C) letter dated March 16, 2017 were sent by FED EX to be received on March 17, 2017. Letters advised users of the reason for the notification, risk to health, affected products with part numbers and a copy of Appendix A - proper use of the Stapler Release Kit (SRK). Customers were instructed to distribute a copy of the letter to all users at their facility, follow all instructions using the Instrument Release Kit (IRK) tool to finish manually unclamping the stapler and return the SRK to Intuitive Surgical through the Returned Material Authorization (RMA) process. Customers were also instructed to log into the da Vinci Online Community Field Action resource (US only) to read or complete any request actions related to this issue. In the case where the da Vinci online resource cannot be used (including outside he US), complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form. Customers were asked to retain a copy of the letter with their Stapler User Manual and the acknowledgement form for their files. If you need further information or support concerning this notification , please contact Intuitive Surgical Customer Service at the numbers listed below: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customersupport-servicesupport@intusurg.com Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) For questions regarding this recall call 408-523-2100.

Quantity

2059 shipped - all versions

Distribution

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

Lot, serial or model codes

Part number: 381382-01

510(k) numbers

["K140553"]

PMA numbers

not on file

Product code

NAY

Firm FEI

3001675293

Firm city

Sunnyvale

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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