FDA-Device2026-04-08Class II

Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, c

Intuitive Surgical, Inc.
Hazard
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Sold states
Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Affected count
86904
Manufactured in
1266 Kifer Rd, Sunnyvale, CA, United States
Products
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended 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. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1696-2026

Original summary

Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended 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. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A Due to increased complaints for broken/frayed grip cables for reusable instruments. Lot Code: 420179: Monopolar Curved Scissors (Hot Shears) GTIN: 00886874111505 FDA Medical Device Number: D088920 Material Number: 420179-10 Batch / System Numbers: M10101102 SH0935 M10101201 SH0935 M10101202 SH1279 M10101203 SH0059 M10101204 USG294 M10101206 USG294 M10101206 SH1378 M10101214 USG022 M10101214 SH0035 M10101214 SH0495 M10110104 SH1279 M10110111 SH1378 M10110112 USG294 M10110113 SH0075 M10110121 SG704 M10110121 SH1279 M10110124 SH0495 M10110126 USG721 M10110126 SH1391 M10110127 USG721 M10110127 SH1279 M10110127 SH2144 M10110202 USG294 M10110202 SH0495 M10110203 SH2144 M10110208 SG704 M10110210 SH1378 M10110216 SH1368 M10110216 USG294 M10110216 SH1391 M10110217 SH0495 M10110217 SH1279 M10110222 SH1279 M10110228 SH0547 M10110228 USG721 M10110228 USG022 M10110228 SH1378 M10110228 SH1279 M10110301 SH1279 M10110303 SH0495 M10110304 USG294 M10110304 SH0729 M10110304 SH0761 M10110307 USG294 M10110308 USG294 M10110308 SH0035 M10110308 SH0495 M10110308 SH1279 M10110311 USG294 M10110311 SH2144 M10110315 USG294 M10110318 USG294 M10110318 SH0935 M10110318 SH1279 M10110323 USG022 M10110324 SH0059 M10110324 USG022 M10110324 SH0495 M10110328 USG294 M10110328 SH0935 M10110328 SH1279 M10110329 USG294 M10110329 SH0935 M10110331 SH0935 M10110405 SH1378 M10110413 USG294 M10110413 SH1279 M10110414 SG704 M10110414 SH0495 M10110420 SH1279 M10110425 SH0035 M10110426 SH0059 M10110428 USG022 M10110429 SG2026 M10110429 SH0035 M10110504 USG294 M10110512 USG294 M10110512 USG022 M10110512 SH2144 M10110517 USG294 M10110517 SH0495 M10110518 SH0035 M10110524 USG294 M10110524 SH1279 M10110525 USG294 M10110526 USG294 M10110526 SH1378 M10110602 SH1279 M10110603 SH1378 M10110614 SH1279 M10110616 SH1368 M10110617 SH1182 M10110617 SH0495 M10110621 SH2144 M10110622 SH0935 M10110623 SH0729 M10110624 SH1378 M10110629 USG294 M10110630 SH1279 M10110630 SH2144 M10110701 SH1378 M10110705 SH0035 M10110711 USG294 M10110712 SH1378 M10110712 SH0495 M10110715 SH1279 M10110715 SH2144 M10110718 SH0761 M10110721 SH0935 M10110728 SH0729 M10110728 SH0761 M10110729 USG721 M10110801 SH1279 M10110802 SH0935 M10110803 USG294 M10110803 USG022 M10110803 SH2144 M10110805 SG704 M10110805 SH0495 M10110808 SH0035 M10110809 USG721 M10110810 SH1279 M10110811 USG022 M10110811 SH0729 M10110812 USG721 M10110812 SH0729 M10110815 SH0935 M10110815 SH1279 M10110816 SG704 M10110816 USG721 M10110816 SH0729 M10110819 USG294 M10110822 SG704 M10110822 USG294 M10110823 SH0729 M10110824 SH0059 M10110824 SH0729 M10110824 SH0495 M10110825 USG721 M10110826 USG721 M10110829 SH1279 M10110830 USG022 M10110902 SG704 M10110902 SH1279 M10110902 SH0761 M10110906 USG022 M10110908 USG721 M10110908 SH1378 M10110908 SH1279 M10110909 SH0495 M10110913 USG721 M10110922 SH2144 M10110923 USG294 M10110923 SH0729 M10110930 SH0935 M10110930 SH0495 M10111003 SG704 M10111004 USG294 M10111005 USG294 M10111006 SH0729 M10111007 SH1368 M10111007 SH0035 M10111007 SH2144 M10111010 SH0935 M10111011 SH0495 M10111011 SH1279 M10111013 SH1378 M10111015 USG022 M10111017 SH1015 M10111018 SH1368 M10111018 SH1279 M10111019 USG294 M10111020 SH0547 M10111020 SH1279 M10111021 USG022 M10111027 SG704 M10111027 SH1378 M10111028 SH0059 M10111028 USG294 M10111028 SH2144 M10111031 SH1015 M10111104 SH1182 M10111107 SH0059 M10111107 SH0729 M10111107 SH0761 M10111108 SH1279 M10111108 SH2144 M10111109 SH0495 M10111111 SH0935 M10111114 USG294 M10111114 SH0729 M10111114 SH1279 M10111115 SG704 M10111115 USG294 M10111115 USG022 M10111116 SH0825 M10111117 SH0729 M10111117 SH1391 M10111117 SH0761 M10111118 SH0935 M10111122 SH0495 M10111122 SH0761 M10111123 SH1390 M10111123 USG294 M10111123 SH0035 M10111124 USG294 M10111129 SH0935 M10111130 SH1378 M10111201 SH1368 M10111202 USG294 M10111202 SH0729 M10111208 USG294 M10111208 SH1279 M10111212 SH1378 M10111213 SG704 M10111213 SH1279 M10111214 USG294 M10111214 SH0729 M10111214 SH1015 M10111216 SH0495

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