FDA Investigating Problems With Da Vinci Surgical Technology

FDA Investigating Problems With Da Vinci Surgical Technology

A failure to report serious mistakes has resulted in the disciplinary review of a Colorado surgeon.

Dr. Warren Kortz is facing 14 counts of unprofessional conduct, levied against him by the Colorado Medical Board, because he failed to report serious issues with the da Vinci robot arm used in kidney surgeries at Porter Adventist Hospital.

Patients from 2008 to 2010 were misled to believe the hi-tech da Vinci robot arm was the safest way to undergo surgery, according to CBS News. Yet it was found the technology was leaving foreign objects, such as sponges and surgical instruments, and tearing blood vessels inside patients.

In 2010 Porter Hospital placed Kortz under precautionary suspension after complications with 11 kidney surgeries.

It has been alleged, by the medical board, that Kortz failed to document all the mistakes in patient charts and that he stopped offering traditional surgery to his patients in favor of using the robot-arm technology.

Kortz’s attorney, in a negligence case against the surgeon, states the patients were forewarned of the associated risks to surgery.

The probe into Dr. Kortz’s actions and conduct emerges just as federal officials are taking a closer look at procedures using the robot technology.

The Food and Drug Administration (FDA) is looking into a spike in reported problems with robotic surgeries. Reports filed since early last year include at least five deaths, Time reveals.

Da Vinci robots operate in several thousand hospitals worldwide. The da Vinci surgical system, a laparoscopic surgery robot, is a widely used tool and performed nearly 400,000 procedures in 2012, according to da Vinci’s maker, Intuitive Surgical Inc. of Sunnyvale, California.

The FDA cleared the da Vinci Surgical System in 2000 for adult and pediatric use in urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and approved for thoracoscopically assisted cardiotomy procedures.

The device is a multi-armed robot that uses a tiny camera on one arm to see into the patient, akin to manual laparoscopy, with surgical instruments on its other arms. Doctors oversee and direct surgery via computer screens. Each unit can cost between $1.5 to $2.5 million and several thousand in maintenance.

The process is intended to be less invasive as the surgery is performed through small incisions instead of cracking open the body. This allows for less down time for healing. The da Vinci has been most commonly used for hysterectomies and prostate removals.

Some surgeons say the robotic method also has advantages when performing weight-loss surgery on extremely obese patients, whose girth can make hands-on surgery challenging.

Critics say there are steep learning curves for surgeons who attempt adopt its use. The da Vinci system uses proprietary software, which cannot be modified, thereby limiting the freedom to adjust the operation system.

An FDA database of reported problems related to the medical device generated nearly 500 reports filed since January 1, 2012. The reports include incidents which do not definitively prove the problems were caused by the robot, and many didn’t injure patients, but complaints were still filed.

One report cited the death of a woman who underwent a hysterectomy in 2012, blaming the surgeon-controlled robot for accidentally nicking a blood vessel. The colon of a New York man was allegedly perforated amidst prostate surgery.

During a colorectal procedure on January 14, the robotic arm failed to disengage and wouldn’t release grasped tissue. During a hysterectomy, it was alleged a patient was struck in the face with the robotic arm. Intuitive Surgical stated they were unaware the patient had been injured, but clarified that the surgeon decided to switch to an open, more invasive operation instead, which likely lead to the woman being hit with the unit during changeover.

Dr. Martin Makary, a Johns Hopkins surgeon who is co-authoring a related research paper, suggests the complaints against robotic surgeries are underreported. “The rapid adoption of robotic surgery has been done by and large without the proper evaluation.”

Currently, the FDA is trying to find out if the commonality of errors is more so in part of the application of the device versus the general statistical risks undertaken when going through standard manual surgery.

Complications can occur with any type of surgery. Manual laparoscopy also has the potential for errors. For example, during what would have been a routine cyst removal became an ovarian extraction (oophorectomy), as the organ was found to be necrotic during a December 2009 outpatient procedure. One unnamed female patient in her 20’s in Kentucky required returning to the hospital ER after a post-op onset of abnormal symptoms, including severe pain, nausea, and the inability to urinate.

Initially it was thought the young woman was suffering from renal failure. It was later discovered, during her prior oophorectomy, the operator had perforated her bladder. She had to undergo an additional surgery to correct the problem, which required the added time and expense of both in-hospital and in-home recovery. For nearly three weeks the woman endured a stoma (surgical opening) and a suprapubic-catheter to reroute the flow of urine until the bladder completely healed.

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