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, appro
Check against the official notice below — it lists the full affected range.
Intuitive Surgical is recalling da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16. 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. Fragments from the extension tube could potentially fall, including into the patient during use. Approximately 23,064 affected instruments were distributed worldwide, including throughout the United States and multiple countries. The devices are identified by specific lot numbers ranging from N10170912 through N1016, among others listed in the recall notice.
The recall affects Model Number 420179-16 with Device Listing D088920 and UDI Number 00886874111505. The source document does not specify a remedy or instructions for what affected consumers should do.
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: 23,064 (S/Si) Lot/code info: 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 N1016
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.