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, appro
Check against the official notice below — it lists the full affected range.
Intuitive Surgical is recalling approximately 42,274 da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors (Model No. 470179-14) distributed worldwide, including throughout the United States and multiple countries. The recalled instruments may develop cracks near the proximal edge of the extension tube, which could cause the plastic surrounding the instrument shaft to fracture and potentially shed fragments during use.
The hazard associated with this recall is that fragments of the extension tube could fall away from the instrument, and these fragments could potentially enter the patient's body during surgical procedures. The recall affects instruments with specific lot numbers manufactured during various dates between 2016 and 2017. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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, Fr Quantity: 42,274 (X/Xi) Lot/code info: 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 S10161
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.