The report, a letter called a Form FDA-483 (found online at fda.gov), was written in response to an FDA inspection of Intuitive Surgical’s facilities. Among the FDA’s concerns were that Intuitive Surgical took action to reduce a health risk linked to the company’s surgical robot without notifying the FDA of those actions. In some cases, the FDA notes, Intuitive sent out recommendations for use due to patient injury associated with the robot, but did not notify the FDA about the recommendations being sent out.
Furthermore, according to the report, Intuitive sent a letter to clients noting that the robots were not approved for thyroidectomy without notifying the FDA. Prior to that, Intuitive reportedly promoted the robot for thryoidectomy. The FDA also noted that although Intuitive received reports of injuries or illness linked to the robot, it did not report those to the FDA.
“Specifically, Intuitive Surgical, Inc. failed to report that there were 5 MDRs associated with the field action taken on 10/13/2011 (Thyroidectomy indication withdrawal). The [report] that was supplied to the San Francisco District Coordinator on 04/11/2013, indicated 0 MDRs in Section 8 on page 3 of 7 of the report. During my inspection of Intuitive Surgical, Inc., 5 MDRs were represented as related to this correction.”
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Arcing occurs when an electrical current jumps from one of the robot’s arms into the patient, potentially causing burns and other serious injury. Lawsuits have been filed against Intuitive Surgical, alleging that patients were seriously harmed during surgeries that involved the company’s robot.