Class 2 Device Recall Intuitive Surgical da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors

• Date Initiated by Firm: August 15, 2018
• Create Date: September 12, 2018
• Recall Status: Open, Classified
• Recall Number: Z-3024-2018
• Recall Event ID: 80696
• 510(K)Number: K180033 K050369
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16; ; Product Usage:; EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. 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, and for benign base of tongue resection procedures, 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: Model Number 420179-16 Device Listing D088920 UDI Number 00886874111505 Lot Numbers: N10170912 N10170928 N10170419 N10170927 N10170919 N10171009 N10170731 N10170529 N11170912 N11170909 N10170828 N10170922 N10161014 N10170522 N10170808 N10170904 N10171010 N10170920 N10170921 N10170804 N10170905 N11170905 N11170725 N10170918 N10170703 N10170911 N11170920 N10171004 N11170227 N10170908 N10170821 N10170801 N10170725 N10170822 N10170524 N10161019 N11160701 N10170705 N11170703 N11170705 N11170522 N11170605 N10170605 N10170516 N10170602 N11170419 N10170308 N11170308 N10170508 N10170303 N12170308 N10170418 N12170310 N10170412 N11170412 N12170412 N10170407 N10170502 N11170207 N10170321 N14170310 N11170202 N11170119 N11170303 N10161129 N13170310 N11170407 N11170214 N11170310 N10170310 N12170214 N10170213 N10170130 N10170202 N11161115 N10170207 N12170123 N10161018 N10170214 N11161014 N10161222 N11170213 N10170119 N11170123 N11161129 N11161212 N10170123 N10161208 N11160926 N11161021 N11170105 N12160707 N10170105 N10161212 N10161115 N11161025 N11161118 N10161118 N10161021 N11161122 N10161026 N10161122 N10161031 N10160701 N11161026 N10161025 N11160608 N10160708 N10160824 N11160629 N11161019 N10160926 N12160824 N11160913 N10160808 N11160808 N10160707 N10160913 N11160622 N13160824 N11160824 N10160608 N10160305 N10160524 N14160824 N11160705 N10160705 N10160714 N10160603 N11160511 N11160708 N10160217 N10160420 N10160429 N10160629 N11160425 N11150929 N10160511 N10160622 N11160429 N10160212 N10160322 N12150929 N10160614 N11160614 N11160603 N10160510 N11160309 N10160523 N11160129 N10160323 N10160328 N10150929 N10160202 N10160425 N10160413 N11160413 N10160406 N10160408 N10160316 N10160401 N10160309 N10160121 N10160129 N10160226 N10160229 N11160301 N10160227 N10160211 N11160202
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 101; Sunnyvale CA 94086-5304
• For Additional Information Contact: 408-523-2100
• Manufacturer Reason for Recall: Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.
• FDA Determined Cause: Use error
• Action: On August 15, 2018, the firm sent an Urgent Medical Device Notification to customers via Federal Express overnight service informing them that certain lots of monopolar curved scissors may be more susceptible to developing cracks near the proximal edge of the extension tube that may cause fragments of the extension tube to fall, including potentially into patients. Customers were advised of the following 1) Always inspect the instruments prior to use for any damage; 2) Use of an instrument for a task other than the instruments designed use may result in breakage or damage; 3) During reprocessing, make certain that the MCS has been adequately rinsed and flushed, and all cleaning chemicals have been removed. Customers were instructed to read and complete actions on the firms website or to fill out and return Acknowledgement Forms to the firm. Customers with questions are encouraged to call Customer Service: - North and South America: 800-876-1310 Option 3 (4 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 KSTJ) - Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) Field Corrective Actions: All customers who received a-16 version of S/Si MCS instrument and the -14 version of X/Xi MCS instrument will receive a customer letter, as a notification of the issue and to reiterate guidelines for proper inspection and use of the MCS instrument. Preventive Actions: The -16 version of S/Si MCS instrument and the -14 version of X/Xi MCS instruments are no longer being shipped to customers. A new design has been introduced to prevent the extension tube from being susceptible to cracking. This new material in has been shown to be robust to environmental stress cracking.
• Quantity in Commerce: 23,064 (S/Si)
• Distribution: Worldwide Distribution - US Nationwide in the states of : AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MA, ME, MD, MI, MN, MS, MO, NB, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY and the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Martinique, Mexico, Monaco, Netherlands, Norway, Pakistan, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Venezuela
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NAY and Original Applicant = Intuitive Surgical, Inc; 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.