Reported Sep 19, 2018 · Ongoing
da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments,…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16
- Product UsageEndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue
- includinggrasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories 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, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use
- Lot codes and dates
- Model Number 420179-16 Device Listing D088920
- UDI Number 00886874111505 Lot Numbers
170 of 170 codes
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
- Amount recalled
- 23,064 (S/Si)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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