Class 2 Device Recall EndoWrist Stapler

• Date Initiated by Firm: March 25, 2016
• Create Date: April 26, 2016
• Recall Status: Terminated on July 01, 2016
• Recall Number: Z-1568-2016
• Recall Event ID: 73736
• 510(K)Number: K131861
• Product Classification: System,surgical,computer controlled instrument - Product Code NAY
• Product: EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software.; ; General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic 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 laparoscopic surgical; procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
• Code Information: da Vinci systems with serial numbers: SK0036 SK0292 SK0650 SK0039 SK0293 SK0652 SK0057 SK0294 SK0653 SK0101 SK0326 SK0654 SK0106 SK0358 SK0665 SK0119 SK0360 SK0701 SK0143 SK0382 SK0702 SK0144 SK0408 SK0710 SK0146 SK0438 SK0722 SK0171 SK0456 SK0728 SK0173 SK0484 SK0181 SK0492 SK0216 SK0496 SK0230 SK0516 SK0233 SK0548 SK0237 SK0552 SK0238 SK0610 SK0263 SK0612 SK0286 SK0631 SK0291 SK0649.
• 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: Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.
• FDA Determined Cause: Software design
• Action: Intuitive Surgical sent an Urgent Product Safety notification to customers via e-mail on March 25, 2016. Customers were advised to STOP USE on the EndoWrist Stapler 45 and 30 instruments on da Vinci XI systems with p5 software. Product letters followed and were mailed on March 31, 2016 by Fed Ex. Urgent Medical Device letters were sent via Fed Ex on March 31, 2016 (dated April 1, 2016). These letters reiterated what was explained in the previous e-mail and provide more information of the unexpected motion issue. In addition to the stop use request, letters requested that all personnel be fully informed of the issue. Further information or support concerning this issue, please contact your Clinical Sales Representative or contact ISI Customer Service at the number: North America: 800-876-1310 Option 3 (6 am to 5pm PST)
• Quantity in Commerce: 43
• Distribution: US Nationwide Distribution in the states of: WI, FL, OH, TX, CA, AZ, IL, MD, MN, NY, OK, HI, MO, IA, KS, PA, and AL.
• 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.