Important Safety Information

Magnetic Surgical System

Read all directions, precautions, and warnings prior to use.

As with any surgical procedure, use of the Levita Magnetic Surgical System involves risk. Potential adverse events include device malfunction or breakage, allergic reaction, injury or damage to the abdominal wall, cavity, or organs (e.g., inflammation, redness), infection, hematoma, bleeding, or petechiae, vascular injury, gastrointestinal injury, organ perforation, and the need for additional surgical intervention, including reoperation. These do not include all risks associated with surgery in general, but are important considerations specific to the use of this device. Individual outcomes may depend on a number of factors, including patient characteristics and surgeon experience.

Rx Only. Prior to use, please review the complete Instructions for Use (IFU) for a full listing of indications, contraindications, warnings, precautions, and potential adverse events.

Indications for Use

The Magnetic Surgical System is indicated for use in patients within a BMI range of 20 to 60 kg/m² and is designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:

• The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures
• The liver in bariatric procedures
• The prostate and periprostatic tissue in prostatectomy procedures
• The colon, rectum, and pericolorectal tissue in colorectal procedures

Grasper Tip, 12.5

Indicated for use in patients within a BMI range of 20 to 60 kg/m² for the pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures.

Pediatric Use

Indicated for use in adolescents (12–21 years) within a BMI range of 20 to 34 kg/m² for the body and fundus of the gallbladder in laparoscopic cholecystectomy procedures.

Surgeon Controlled Arm. Indications for Use

The Surgeon Controlled Arm is indicated for use to hold and position a rigid scope and the Magnetic Controller of the Levita Magnetic Surgical System in minimally invasive interventions where the Levita Magnetic Surgical System is indicated for use.

Contraindications

• Do not use on patients or near anyone with pacemakers, defibrillators, or other electromedical implants.
• Do not use on patients or near anyone with ferromagnetic implants.

These contraindications apply to both the Magnetic Surgical System and the Surgeon Controlled Arm accessory.

Warnings and Precautions

The Magnetic Surgical System is intended for use only by physicians with expertise in laparoscopic surgical techniques who are trained on this device, and it should always be operated under visualization. Safety and effectiveness have not been established in patients with a BMI outside the 20–60 kg/m² range for which the system is indicated.

The Magnetic Controller contains a strong magnet. Defined safe working distances must be maintained between the Magnetic Controller and cardiac pacemakers or other medical implants, cathode-ray tube equipment, magnetic data storage, ferromagnetic objects, and general electrical equipment (refer to IFU for specific safe working distances).

The Magnetic Grasper is a single-use device and must not be resterilized or reused, and must not be introduced or withdrawn through a trocar with the jaws open.

See the Instructions for Use of the Magnetic Surgical System for the complete Contraindications and Warnings and Precautions applicable to the Surgeon Controlled Arm accessory.

Potential Adverse Events

Potential adverse events associated with the use of the Magnetic Surgical System include:

• Malfunctioning of the device
• Breakage of the device
• Allergic reaction related to the device
• Abdominal wall/cavity/tissue and/or organ injury or damage (e.g., inflammation, redness)
• Infection
• Hematoma, bleeding, or petechiae
• Vascular injury
• Gastro-intestinal injury
• Organ perforation

Additional surgical intervention due to any of the above factors (includes reoperation)

These adverse events do not include all adverse events that occur with surgery in general, but are important considerations particular to laparoscopic instrumentation.