Search Results

The da Vinci Force Feedback Instruments are 8 mm, multi-use endoscopic instruments intended to be used with the da Vinci Surgical System, Model IS5000. These instruments have an articulating wrist that gives surgeons natural dexterity and range of motion, and possess the ability to render forces measured at the instrument tip to the hand controls at the Surgeon Console of the IS5000 System. Each instrument performs one or more surgical tasks such as suturing, grasping, and tissue manipulation.

Indications for use of the da Vinci Force Feedback Instruments are covered as part of the da Vinci Surgical System, Model IS5000. The most recent cleared indications for use, which are not anticipated to be modified in the upcoming 510(k), are listed for reference below.

Da Vinci Surgical System, Model IS5000:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, 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 and general thoracoscopic surgical procedures. The system is indicated for adult use.

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.

Contraindication:

Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

The da Vinci Force Feedback Instruments are 8 mm, multi-use, endoscopic instruments intended for use with the da Vinci Surgical System, Model IS5000. These instruments have been designed with an articulating wrist that gives surgeons natural dexterity and range of motion, and have the ability to render forces measured at the instrument tip to the hand controls at the system Console.

The devices listed in Table 1 below are the subject devices of this premarket notification, which Intuitive intends to introduce into interstate commerce in accordance with 21 CFR Section 807.81.

Table 1: Subject Devices

Model Number Device Description
477006 da Vinci Force Feedback Large Needle Driver
477049 da Vinci Force Feedback Cadiere Forceps
477093 da Vinci Force Feedback ProGrasp Forceps
477172 da Vinci Force Feedback Maryland Bipolar Forceps
477205 da Vinci Force Feedback Fenestrated Bipolar Forceps
477309 da Vinci Force Feedback Mega SutureCut Needle Driver

N/A

Ask a specific question about this device