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.
FDA Recall Z-3024-2018 · Posted None
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Recalling FirmIntuitive Surgical, Inc.
Recall StatusOpen, Classified
Product CodeNAY
Date Initiated2018-08-15
Product Quantity23,064 (S/Si)
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.
Firm 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.
Root Cause
Use error
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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