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U.S. Department of Health and Human Services

Class 2 Device Recall STAPLER 45, IS4000, model number 470298

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  Class 2 Device Recall STAPLER 45, IS4000, model number 470298 see related information
Date Initiated by Firm July 14, 2016
Date Posted August 05, 2016
Recall Status1 Terminated 3 on January 03, 2017
Recall Number Z-2348-2016
Recall Event ID 74705
510(K)Number K140553  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product STAPLER 45, IS4000, model number 470298

Gastroenterology/Urology: 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
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		 An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
FDA Determined
Cause 2		 Software design
Action Field Safety Notifications - Urgent Medical Device Corrections and Removal letters were sent on July 15, 2016 (dated July 14, 2016 advised users of the Stapler Firing Failed message and actions to take should the message be received.
Quantity in Commerce 2065 total
Distribution US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.
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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