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What Happens When the Surgical Robot Malfunctions?

Tuesday, 19 Mar 2013 | 11:08 AM ET
Source: Intuitive Surgical

Like all computers, Intuitive Surgical's da Vinci can malfunction during surgery.

With the da Vinci, the most common event "involves instrument cable breaks," the company said in a recent statement. "These cable breaks render the instrument non-functional and require an instrument change, which can be accomplished quickly."

However, surgeons using the robot realize more serious malfunctions are a possibility.

In a court deposition related to alleged da Vinci complications in one of his surgeries, Washington urologist Scott Bildsten said, "One problem you can run into is sword fighting—you're clanging your arms together and fighting each other, in which case they can build up unnecessary tension."

A random review of da Vinci-related "adverse events" on the FDA database contains a number of reported incidents where robots seemingly malfunctioned, some with serious noteworthy results.

For example, during a hysterectomy on Jan. 2, according to the database, "It was stated that the arm jumped, causing the instrument … to stab an artery, which led to some bleeding that the surgeon was able to control without converting the procedure. The scheduled procedure was completed successfully."

In another hysterectomy, on Jan. 4, "the patient's ureter was damaged. During repair of the patient's ureter by the site's urologist, the urologist noted that the jaw on the EndoWrist instrument installed on the patient side manipulator arm was not articulating correctly. ... Unable to resolve the issue, the surgeons made the decision to repair patient's ureter and complete the surgical procedure using open surgical techniques."

And in yet another hysterectomy, on Dec. 28, "the bipolar instrument fired unintentionally during a procedure. ... The instrument tip did touch the patient's uterus [and] the customer was able to successfully complete the case plus two additional cases using the same generator with no further incidents."

Then there was a hysterectomy on Dec. 13. According to the FDA database, "It was reported ... the da Vinci system hit the patient in the face. It was unknown if the patient was injured during this time. The surgeon made the decision to convert the procedure to traditional open surgical techniques to complete the procedure."

It is important to note that submissions to the FDA database are voluntary, based only on reported cases and have not necessarily been investigated by the agency.

More: The Da Vinci Code...Growing Sales, Growing Concerns

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