Safety Information

Indications for Use

The MIRA Surgical System is a miniaturized robotic assisted surgery device indicated for the mobilization of the colon in adults at least 5'0” (1.52 m) tall and having a weight of at least 100 lbs (45.36 kg) who are undergoing minimally invasive colectomy procedures.

It is intended to assist in the visualization of tissues and provide accurate and precise control of surgical instruments to grasp, retract, and dissect while maintaining hemostasis with electrocautery during manipulation of tissues.

It is for prescription use only and is to be used by trained physicians in any operating room environment.

Safety Information

The demonstration of safety and effectiveness was based on evaluation of the MIRA Surgical System as a surgical device and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.

Serious complications may occur with any surgery, including surgery with the MIRA Surgical System, up to and including death. In addition, there are risks that are specific to certain surgical procedures. Certain pre-existing medical conditions can also increase the risks of any surgery. Surgeons should discuss pertinent surgical risks with their patients.

Section 1 includes the adverse events, risks, and complications of any type of surgery.
Section 2 includes the adverse events, risks, and complications of minimally invasive surgical techniques.
Section 3 includes the adverse events, risks, and complications of surgery with the MIRA Surgical System.
Section 4 includes the adverse events, risks, and complications of representative, specific surgical procedures.

Section 1: Adverse events, risks, and complications of any surgical type

This section covers potential adverse events, risks, and complications associated with common types of surgery in general and are not specific to the surgical method or approach used.

Common approaches/methods of surgery include: open surgery (through a large incision), laparoscopic surgery (through a few small incisions or the belly button) with traditional laparoscopy or robotic-assisted laparoscopy with the MIRA Surgical System. Complications include but are not limited to:

a. Intraoperative

Bleeding requiring blood transfusion or causing hemodynamic instability
Injury (inadvertently caused by laceration, tear, perforation, puncture, electrocautery) to organ, structure, or tissue, including, but not limited to: major blood vessels, organs, ureters, and nerves
Loss of needle, instrument fragment, or any foreign body during surgery in patient’s body
Anesthesia risks (including heart attack, stroke, deep venous thrombosis, pulmonary embolism, pneumonia, dental injury, vocal cord injury, and death)
Patient-positioning injury: hemodynamic, intraocular pressure, neurologic, soft tissue injuries
Death

b. Postoperative

Bleeding
Wound infection: incisional
Serous drainage from wound, prolonged or excessive
Fascial dehiscence: incisional
Urinary: urinary tract infection, urinary retention
Gastrointestinal: ileus, nausea/vomiting, small bowel obstruction
Infection / hematoma / fluid collection / abscess (intra-abdominal, intra-pelvic, intra- thoracic, sepsis)
Cardiac: myocardial infarction, arrhythmia, pericarditis
Thromboembolic: deep venous thrombosis, pulmonary embolus
Pulmonary: atelectasis, pneumonia, pleural effusion, pulmonary edema, need for re-intubation or prolonged intubation
Peritonitis
Rhabdomyolysis
Injury to adjacent organs
Hernia: incisional
Renal failure
Neuropathy; persistent pain
Worsening oncological outcomes
Cerebrovascular: transient ischemic attack, ischemic or hemorrhagic stroke
Recurrence of disease or symptoms
Visual loss, temporary or permanent
Inability to work
Coma
Death

These complications may resolve on their own, may require medical/pharmaceutical treatment such as antibiotics, may require radiological intervention such as drain placement or embolization, may require prolonged hospitalization, may require re-admission to the hospital, or may require additional procedures or surgical intervention such as re-operation.

Section 2: Adverse events, risks, and complications of minimally invasive surgery

This section covers potential adverse events, risks, and complications associated specifically with operative procedures performed minimally invasively through an endoscopic approach in addition to the above listed risks (for example, conventional laparoscopy and robotic-assisted surgery using the MIRA Surgical System). Complications include but are not limited to:

Conversion to open surgery (typically due to patient anatomy, severe inflammation or adhesions, intraoperative injury, technical malfunction, extent of malignant invasion, extent of disease, or inability of patient to tolerate pneumoperitoneum). Switching to another surgical approach could also result in a longer procedure time, a longer time under anesthesia and increased complications.
Veress needle or trocar injury to organs or blood vessel(s)
Longer operative and anesthesia time
Air/gas entering the bloodstream leading to heart dysfunction or stroke
Ocular or laryngeal-facial complications related to Trendelenburg position
Subcutaneous emphysema
Hemodynamic and physiologic changes from the pneumoperitoneum and gas used
Postoperative shoulder pain resulting from insufflated gas

Section 3: Adverse events, risks, and complications of robotic–assisted surgery using the MIRA Surgical System.

In addition to Section 1 and 2 above, which are not unique to the MIRA Surgical System, this section covers potential negative outcomes, risks, and complications of robotic-assisted surgery using the MIRA Surgical System. As with any surgical device, there is the risk that the MIRA Surgical System could malfunction or fail, leading to serious injury or the need to switch to another type of surgical approach.

Section 4: Adverse events, risks, and complications of representative specific procedures

In addition to Section 1–3, this section covers potential negative outcomes of representative specific procedures indicated for the MIRA Surgical System.

Risks associated with colectomy procedures may include anastomotic leak, anastomotic stricture, colorectal or anorectal dysfunction.

Disclosure and Important Safety Information

The MIRA Surgical System is intended for prescription use only. Patients should talk to their doctor to decide if surgery with a MIRA Surgical System is right for them. Patients and doctors should review all available information on nonsurgical and surgical options and associated risks in order to make an informed decision.

Serious complications may occur in any surgery, including minimally invasive surgery with the MIRA Surgical System, up to and including death. Serious risks include, but are not limited to, injury to tissues and organs, and/or conversion to other surgical techniques which could result in a longer operative time and/or complications.

For important safety information, including surgical risks and considerations, please also refer to www.virtualincision.com/safety-information. For the product’s indications for use, risks, full cautions, and warnings, please refer to the associated user manual(s).

Individual outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics, surgeon, and/or hospital experience.

MIRA Surgical System Precaution Statement

The demonstration of safety and effectiveness for the representative specific procedures was based on evaluation of the MIRA Surgical System as a surgical device and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.