United StatesThe affected products are Intuitive Surgical da Vinci S and Si EndoWrist reusable instruments: Monopolar Curved Scissors (model/catalog number 420179), Double Fenestrated Grasper (420189), Mega Needle Driver (420194) and Grasping Retractor (420278), identifiable by those product names and model/catalog numbers. They were recalled because of increased complaints of broken or frayed grip cables.
What's being recalled
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…
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA 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…
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA 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…
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA 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…
Recalling firm: Intuitive Surgical, Inc., Sunnyvale, CA, United States.
How to identify it
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…
The hazard
Due to increased complaints for broken/frayed grip cables for reusable instruments.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)