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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 March 03, 2015
Date Posted March 20, 2015
Recall Status1 Terminated 3 on September 08, 2015
Recall Number Z-1303-2015
Recall Event ID 70705
510(K)Number K131861  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product da Vinci Xi Surgical System, IS4000;
ASSY,DISTAL SUJ,OUTER,IS4000,
Material number: 380663-20 and 380663-21.

The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders,
endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical
procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.
Code Information Material number: 380663-20; Serial numbers: 1311140532, 1311140035, 1311140475, 1311140424,  1311140196, 1311140146, 1311140252, 1311140010, 1311140289, 1311140578, 1311140435, 1311140349, 1311140411, 1311140389, 1311140156, 1311140198, 1311140452, 1311140186, 1311140554 1311140335, 1311140249. Material number 380663-21: Serial numbers: 1311140047, 1311140541, 1311140181, 1311140352 1311140023, 1311140165, 1311140159, 1311140126, 1311140571, 1311140397, 1311140130, 1311140318, 1311140180, 1311140151 1311140375, 1311140428, 1311140528, 1311140263, 1311140169 1311140443, 1311140537, 1311140544, 1311140419, 1311140006 1311140583, 1311140173, 1311140154.   
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		 Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Intuitive Surgical, sent an "Urgent Medical Device Correction" letter dated March 11, 2015 to its consignees/customers on March 11, 2015 via Fed Ex. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that all affected personnel are fully informed of this notice; forward this notice to your Risk Manager, OR Director, Purchasing Manager, biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures; Identify systems containing affected product at your site; if you encounter this error during a procedure and the fault cannot be recovered, disable the affected arm and contact dVStat; Contact Intuitive Surgical Customer Service; Complete and return the attached Acknowledgment Form to Intuitive Surgical via U.S. Fax +1 (408) 716-3040, or Scan and Email: isi.compliance@intusurg.com, ATTN: REGULATORY COMPLIANCE-Subject line for email: Pot to Encoder;and retain a copy of this notice for your records. An Intuitive Surgical representative will contact you to schedule a remote assessment to determine the health of your system and to schedule an appointment to replace the affected arm. If you need further information or support concerning this Medical Device Correction, please contact your Clinical Sales Representative or Intuitive Surgical Customer Service at the numbers listed below: -North America and South America: 800-876-1310, Option 3 (6 AM to 5 PM PST) -Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) -South Korea: 02-3271-3200 (9 AM to 6 PM KST) -Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com.
Quantity in Commerce 167 total affected da Vinci XI systems
Distribution Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, France, Germany, India, Israel, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
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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