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U.S. Department of Health and Human Services

Class 2 Device Recall EndoWrist Stapler System User Manual Addendum and Wall Chart

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  Class 2 Device Recall EndoWrist Stapler System User Manual Addendum and Wall Chart see related information
Date Initiated by Firm June 02, 2014
Date Posted August 08, 2014
Recall Status1 Terminated 3 on August 08, 2014
Recall Number Z-2171-2014
Recall Event ID 68814
510(K)Number K113706  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product EndoWrist Stapler System User Manual Addendum and Wall Chart;

The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
Code Information Model number 410298-05 and 410298-06
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		 Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for the enzymatic cleaner used throughout the cleaning process was modified from pH-neutral to pH-neutral to mild alkaline (mild alkaline is defined as pHd11). Mild Alkaline enzymatic
FDA Determined
Cause 2		 Labeling Change Control
Action Intuitive Surgical representatives hand delivered corrected manuals to the two affected sites..
Quantity in Commerce 2
Distribution Distribution to Florida and South Carolina
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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