Robotic Surgery Firm Faulted in FDA Report

June 27, 2013

The US Food and Drug Administration (FDA) has faulted Intuitive Surgical, the manufacturer of the da Vinci robotic surgical system, for failing to report measures it took to guard patients from accidental electrical burns, according to an agency inspection report issued May 30.

The company told Medscape Medical News that it has "implemented corrective actions" for this and other infractions cited in the report.

Intuitive Surgical finds itself under increasing FDA scrutiny in light of a 34% increase in incidents — some fatal — associated with the da Vinci system that were reported to the agency from 2011 to 2012. During that same period, the volume of da Vinci procedures in the United States increased 26%, according to the manufacturer.

Installed at some 2000 US hospitals, the computerized system lets a surgeon manipulate instruments attached to robotic arms while viewing the procedure in 3 dimensions. The system, which has competed with laparoscopic technology, is widely used for hysterectomy and prostatectomy. It has also been used for abdominal procedures, including gastric bypass.

In January, the FDA began surveying surgeons who use the system about user training, common equipment repairs, patient selection, the complications they witness, and what procedures are the best and least suited for this form of robot-assisted surgery. An FDA spokesperson told Medscape Medical News that the agency has not yet completed a report on its findings.

The FDA inspected Intuitive Surgical's headquarters in Sunnyvale, California, repeatedly in April and May, leading to the report issued on May 30.

According to the report, the company had not notified the FDA of 4 separate "field actions" designed to "reduce the risk to health posed by a device." In the earliest incident, Intuitive Surgical sent a letter to its customers on October 10, 2011, with instructions on the proper use of surgical instruments with insulating tip covers and on the correct electrical generators for monopolar cautery instruments. The instruments are so named because electric current passes from a single electrode, with the patient's tissue acting as a ground. The FDA said this letter came in response to complaints and medical device reports (MDRs) filed with the agency about electrical arcing through damaged tip covers that burned patient tissue.

The company had received 134 complaints about "tip-cover issues" — and filed 82 MDRs in the process — during 2010 and 2011, according to the inspection report.

The company also did not tell the FDA that it had sent another letter to its customers in October 2011 with information about, among other things, inspecting cannulas used to insert instruments into the body. The FDA report said that one of the sources of injurious electrical arcing is tip-cover damage caused by defective cannulas.

In addition, the FDA cited Intuitive Surgical for not sharing that it had informed clients that the da Vinci system was not approved for thyroidectomy after promoting its technology for this procedure, and that da Vinci–style transoral surgery was not indicated for pediatric patients.

In an email to Medscape Medical News, company spokesperson Geoff Curtis said the FDA had reclassified these various field actions from nonreportable to reportable, resulting in the inspection citations. The company posted the required notifications to the FDA Web site on May 29, he said.

In addition to failing to inform the FDA about various corrective measures, Intuitive Surgical also ran afoul of requirements for documenting equipment design and 5 MDRs associated with thyroidectomies, according to the inspection report.

Intuitive Surgical has fixed these problems as well, Curtis said. "We take our regulatory obligations seriously."


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