| Class 2 Device Recall STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit | |
Date Initiated by Firm | March 15, 2017 |
Create Date | April 05, 2017 |
Recall Status1 |
Terminated 3 on December 10, 2018 |
Recall Number | Z-1723-2017 |
Recall Event ID |
76754 |
510(K)Number | K140553 |
Product Classification |
System,surgical,computer controlled instrument - Product Code NAY
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Product | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Japanese 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). |
Code Information |
Part number: 381390-01 |
Recalling Firm/ Manufacturer |
Intuitive Surgical, Inc. 1266 Kifer Rd Bldg 100 Sunnyvale CA 94086-5304
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For Additional Information Contact | Mark Johnson 408-523-2100 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 2059 shipped - all languages |
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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = NAY
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