Recall Z-3025-2018 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
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 Contr
| Date | Aug 15, 2018 |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 reprocessi |
| Quantity | 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, Austr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc., Mar 28, 2014 |