Intuitive Surgical Gains Clearance for Another da Vinci Surgical System Instrument

Intuitive Surgical said it has received FDA clearance for another instrument for its da Vinci Si Surgical System, the Single-Site Wristed Needle Driver. The instrument was cleared for use in performing minimally invasive hysterectomies, removing ovaries and fallopian tubes, as well as removal of the gallbladder, the devicemaker said.

The Single-Site instrument enables virtually scarless surgeries via a single-incision, and gives surgeons robotic and computer assistance. This allows for surgical precision, control, stability, 3D-HD visualization and an ergonomic seated position, the Sunnyvale, Calif. company said.

The 5 mm Wristed Needle Driver was developed to facilitate suturing after removal of the uterus, Intuitive said. It can move the instrument tip up to 45 degrees in all directions and features serrated jaws to facilitate needle handling.

The system and instruments are designed to minimize instrument crowding and maximize working space compared with standard, hand-held, laparoscopic single-incision instrumentation, the devicemaker noted.

The device is now available in the U.S. The company next will focus on securing regulatory approval globally, it said.  — Kellen Owings

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