Class 2 Device Recall Intuitive Surgical da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors

• Date Initiated by Firm: August 15, 2018
• Create Date: September 12, 2018
• Recall Status: Open, Classified
• Recall Number: Z-3025-2018
• Recall Event ID: 80696
• 510(K)Number: K131861
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14; ; 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 47179-14 Device Listing D215864 UDI Number 00886874112298 Lot Numbers: S11160307 N11171009 N10171010 N10171012 N10180219 N10180214 N10180212 N10180220 N10180221 N10171017 N10180213 N10180215 T10180212 N11180212 T10180208 N10171002 N10170921 N10171023 N10171018 N10170819 N10170818 N10170911 N10170807 N10170808 N10170914 N10171016 N10170718 N10171019 N10171005 N10171009 N10171004 N10171003 N11170911 N10170927 N10170926 N10170815 N11170922 N11170912 N10170809 N10170814 N10170925 N10170922 N10170728 N10170713 N10170912 N10170614 N10170906 N10170824 N10170703 N10170816 N10170811 T10170720 N10170727 N10170724 N10170712 N10170803 N10170721 N10170802 N10170602 N10170720 N10170620 N10170719 N10170801 N10170714 N10170619 N10170711 S10170525 N10170626 N10170613 N11170513 N10170706 N11170223 N10170531 N10170628 N10170612 N10170629 S10170705 S10170523 N10170616 N10170605 N10170615 N10170307 N10170622 N10170518 N10170609 N10170607 N10170504 N10170606 N11161213 N10160831 N10170317 N10170418 N10170601 N10170526 N10170405 N10170511 N10170524 N10170522 N10170508 N10170519 N10170513 N10170515 N11170306 N10170509 N10170516 N10170428 N12170223 S10170501 S10170223 N11170429 N10170427 N11170428 N10170406 N10170429 N10170426 N10170420 N10170424 N10170419 N10170324 N10170328 N10170417 N11170224 S10170417 N10170411 N10170224 N10170412 N10170410 N10170303 N10170404 N11170120 N11170405 N10170403 S10170405 N10170331 N10170302 N10170314 N10170321 N10170131 N10170306 N11170327 N10170309 S10161213 N10170327 N10170117 N10170323 N10170301 N10170313 N10170316 N10170315 N11161117 S10170317 N10170310 N10170227 N10170216 N11161215 N12170306 N10170222 N11170216 S10161130 N11170301 N10170228 S10170224 N10170223 N10170127 N10170217 N10170214 N10170209 N10170207 N11170214 N11170117 N10170215 N11170104 N10170210 N10170208 S10170125 N10170110 N10170112 N10170203 N10170130 N10170123 N11170123 S10161207 N10170120 N11170112 S10170120 N10170125 S10161208 S10170201 N11170125 N10170104 S10170126 N10170119 N10161205 N10161216 N10161228 N11170110 N11161216 N10161117 N11161130 N11170105 N10161202 N10161026 N10170105 N10161004 N11161221 N10161011 N10161229 N11161212 N11161209 N10161221 N10161215 N11161014 N10161214 S10161117 N10161213 N10161212 N10161124 N10160921 N10161209 N10161130 S10160922 N11161122 N10160809 N10161107 N10161122 N11161114 N11161111 N11161107 S10161116 N10160912 N10161111 N10160908 N10161103 S10160901 N10161114 N10161018 N10161104 N10161110 N11161104 N10160802 N10161102 N10160727 S10161108 S10160428 N11161028 N10161006 N10161025 N10161028 N10161024 N10160919 S10161024 N10161021 N11160905 N10161014 N11161018 S10161020 N10160915 S10161019 S10161013 N10160822 S10160307 S10161012 N10160824 N11161006 N11160706 N10160719 N11160912 S10161003 N10160914 N11160816 N10160926 N10160816 N10160525 N11160926 S10160614 N10160920 S10160927 S10160527 N10160811 S10160916 N10160905 N10160825 N11160831 S10160811 N11160725 S10160728 S10160718 N10160823 N11160825 S10160712 S10160705 N11160427 N10160728 S10160817 N11160808 S10160815 N10160808 N10160801 N11160601 N10160725 N10160803 N10160527 S10160803 N10160607 N10160714 N10160720 S10160713 S10160506 S10160629 N10160713 N11160720 N11160714 N11160628 N10160708 N10160405 N10160706 N10160628 N10160701 S10160324 N10160624 N11160624 S10160321 N10160617 N10160526 N10160615 N10160620 N10160613 N10160610 N10160608 S10160415 N10160506 N10160606 N10160519 N10160601 N10160517 N10160524 S10160513 N10160520 N10160516 N10160418 N10160513 N10160512 N10160511 N10160505 N12160316 N10160504 N10160428 N10160427 N10160316 N11160316 S10160422 N10160426 N10160419 N10160331 N10160414 N10160412 N10160329 S10160406 S10160318 N10160404 S10160401 S10160302 S10160325 N10160301 S10160229 S10160227 S10160219 S12160114 S11160114 S10160114
• 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: 42,274 (X/Xi)
• 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.