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U.S. Department of Health and Human Services

Class 2 Device Recall daVinci EndoWrist(R) Stapler 45

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  Class 2 Device Recall daVinci EndoWrist(R) Stapler 45 see related information
Date Initiated by Firm September 19, 2017
Create Date January 23, 2018
Recall Status1 Terminated 3 on January 30, 2024
Recall Number Z-0404-2018
Recall Event ID 78908
510(K)Number K140553  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product daVinci X EndoWrist(R) Stapler 45, REF 470298

Product Usage:
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci 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 the same staple line or tissue buttressing material (natural synthetic).
Code Information UDI 00886874112427: Serial Numbers: S10170630, S11170705, S10170707, S10170731
Recalling Firm/
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact Intuitive Surgical Customer Service
800-876-1310 Ext. 3
Manufacturer Reason
for Recall
Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.
FDA Determined
Cause 2
Process control
Action The firm initiated their recall by email on 09/19/2017 and followed with a letter delivered by FedEx on 09/20/2017. The notice requested the following actions: "Please take the following actions to ensure all affected personnel are fully informed of this Field Safety Notice. Forward this letter to your Risk Manager, OR Director, Purchasing, Biomedical Engineering staff, and other members of your medical staff who are involved with da Vinci procedures. 1.Using the lot numbers listed above, please locate and return all affected Staplers at your site via the standard RMA process. a. Credit will be provided for remaining uses on affected instruments returned to Intuitive Surgical. 2.Please log into the da Vinci Online Community field action resource to read and/or complete any requested actions related to this issue. a. https://www.davincisurgerycommunity.com/ 3.If you cannot access the da Vinci Online Community field action resource, please complete the attached Acknowledgement Form and return it via fax or email to Intuitive Surgical per the instructions contained in the Acknowledgement Form. 4.Please retain a copy of this letter and a copy of the Acknowledgement Form for your files."
Quantity in Commerce 60 units
Distribution US Nationwide Distribution
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.