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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci Xi" Surgical System

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  Class 2 Device Recall da Vinci Xi" Surgical System see related information
Date Initiated by Firm November 03, 2014
Date Posted November 25, 2014
Recall Status1 Terminated 3 on February 03, 2015
Recall Number Z-0445-2015
Recall Event ID 69638
510(K)Number K131861  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product 8MM, SMALL GRASPING RETRACTOR ;

Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Code Information Part number; 470318-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
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		 Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
FDA Determined
Cause 2		 Labeling design
Action Urgent Medical Device Recall letters were sent to affected sites on November 3, 2014. Letters inform customers of the reason for recall, risk to health and the affected instrument. A table of all of the affected IS4000 instruments affected is attached to the letter indicating the part number and product name for each. Letters also inform customers that all instruments shipped since July 2014 are manufactured with a new material and not subject to recall. Customers are to take the following actions: 1. Ensure that all affected personnel are aware of the information. 2. Identify affected product in their possession 3. Contact ISI rep for replacement. 4. Complete and return the attached Acknowledgement From. Until replacement instruments are received, the old instruments may be used provided they do not show signs of degradation and that the reprocessing instructions are followed. Questions to 800-876-1310 Option 3 ( 6 am to 5 pm PST) or ics@intusurg.com.
Quantity in Commerce 509 total units, all affected devices
Distribution US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
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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