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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci Si" Surgical System

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  Class 2 Device Recall da Vinci Si" Surgical System see related information
Date Initiated by Firm September 18, 2014
Date Posted October 16, 2014
Recall Status1 Terminated 3 on March 03, 2015
Recall Number Z-0074-2015
Recall Event ID 69283
510(K)Number K123463  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product EndoWrist Stapler 45 instrument for the da Vinci Si System

Model Number: IS3000



Product Usage:
For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Code Information EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots.
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		 Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.
FDA Determined
Cause 2		 Device Design
Action Intuitive Surgical sent an Urgent Product Notice letter dated September 19, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: -Immediately stop using the EndoWrist Stapler 45 instrument. -Quarantine the EndoWrist Stapler 45 instruments within your hospital. Keep the instruments quarantined until Intuitive Surgical sends you a subsequent communication with instructions regarding the quarantined product. -Ensure 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 Si surgery procedures using the EndoWrist Stapler 45 instrument. -Please retain a copy of this notice for your records with your da Vinci Si User Manual. If ¿you ¿need ¿further ¿information ¿or ¿support ¿concerning ¿this ¿Product ¿Notice, ¿please contact your Clinical Sales Representative or Intuitive Surgical Customer Service at 800-876-1310 Option ¿3 ¿(6 ¿am ¿to ¿5 ¿pm ¿PST). ¿
Quantity in Commerce 1,034 Devices
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.
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