Recall Z-1718-2017 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Finnish 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, Gynecolog
| Date | Mar 15, 2017 |
| Status | Terminated |
| 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 M |
| Quantity | 2059 shipped |
| 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, Sw |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140553 | ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS Intuitive Surgical, Inc., Jul 25, 2014 |