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U.S. Department of Health and Human Services

Class 2 Device Recall STAPLER,IS4000

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  Class 2 Device Recall STAPLER,IS4000 see related information
Date Initiated by Firm July 14, 2016
Date Posted August 26, 2016
Recall Status1 Terminated 3 on January 03, 2017
Recall Number Z-2675-2016
Recall Event ID 74811
510(K)Number K140553  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product STAPLER,IS4000; Model number 470298;

General and Plastic Surgery:
The Intuitive Surgical da Vinci 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 All model 470298
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Mark Johnson
408-523-2100
Manufacturer Reason
for Recall		 Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Intuitive sent a Stop Use e-mail to all affected sites on July 14, 2016 to inform users of the issue prior to the commencement of a recall. E-mail described the problem and asked that all surgeons who use the stapler be informed to immediately stop use. Formal letters will follow. Medical Device Recall letters were sent on July 21, 2016. Customers were instructed to return quarantined affected product whether used or unused to Intuitive Surgical. Customers should contact customer service to initiate the standard Return Material Authorization (RMA) process by phone or email: North and South America: 800-876-1310, option 3 (6AM to 5PM PST) Email: customersupport..servicesupport@intusurg.com Europe, Middle East, Asia and Africa Phone: 800-821-2020 or +41 21 821 2020 Email: ics@intusurg.com Customers were also instructed to complete the attached Return Acknowledgement Form and submit via email to Regulatory Compliance at isi.compliance@intusurg.com or by fax to +1 (408) 523-0619. For questions regarding this recall call 408-523-2100. 10-31-16 Update: Monthly status update states that an additional 93 instruments have been identified and an additional communication will be sent to these sites in Mid November 2016,
Quantity in Commerce 875 instruments (827 a la carte + 48 in kits) total, all models
Distribution Worldwide Distribution - US (nationwide) Internationally to Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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