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