FDA-Device2026-04-08Class IIPROCESSING DEFECT
Intuitive Surgical da Vinci Tenaculum Forceps recalled for frayed or broken pitch cables
OTHERNationwide distribution
Check da Vinci Tenaculum Forceps for cable damage
Intuitive Surgical is recalling certain da Vinci S and Si Tenaculum Forceps instruments (Model 420207) because the internal pitch cables that control the instrument tip can fray or break during use. This could affect the surgeon's ability to control the instrument properly during a procedure. No injuries have been reported so far.
- If your facility uses da Vinci S or Si systems, check if you have any affected instruments with material numbers 420207-06, 420207-07, 420207-09, or 420207-10
- Visually inspect the instrument for frayed or broken cables before use
- Contact Intuitive Surgical or your equipment supplier for replacement or repair instructions
- Report any cable problems to the FDA MedWatch program
Hazard
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Sold states
U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, and WA. The countries of Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Affected count
2095 instruments
Manufactured in
1266 Kifer Rd, Sunnyvale, CA, United States
Products
Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 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-1700-2026More Intuitive Surgical, Inc. recalls
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Cautery Hook instruments recalled for frayed or broken cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Mega Needle Driver recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S/Si Grasping Retractor recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S and Si Monopolar Curved Scissors recalled for broken grip cables
- FDA-Device2026-04-08Intuitive Surgical da Vinci S, Si Double Fenestrated Grasper recalled for broken grip cables
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