Shares of Intuitive Surgical, Inc. (ISRG: Quote) declined more than 2 percent in extended trades on Tuesday after the U.S. Food and Drug Administration said that the surgical systems maker warned clients about problems with its da Vinci surgical robots without first informing regulators. Intuitive's da Vinci surgical robots are used in robotically assisted minimally invasive surgery.
In a Form 483 letter following inspections at Intuitive's facility from April 1 to May 30, 2013, the FDA cited four main observations.
The FDA noted in its observations that a correction or removal conducted by Intuitive to reduce risk to health posed by its devices was not reported in writing to the agency. Intuitive also did not report injuries or illnesses that occurred with the use of correctable devices, did not adequately establish procedures for design changes and failed to adequately document input requirements.
The FDA noted that Intuitive undertook four field actions between October 2011 and January 2013, but did not notify the San Francisco District Recall Coordinator of these actions.
According to the FDA, Intuitive sent out a letter to da Vinci clients on October 10, 2011 with suggestions and recommendations for the proper use of instruments with tip covers and for the correct generators that should be used with monopolar instruments.
This correction was in response to complaints and MDRs for arcing though damaged tip covers that caused injury to patients. The FDA said that between January 2010 and December 2011, Intuitive received 134 complaints and filled 82 MDRs related to tip cover issues.
The FDA noted that Intuitive sent another letter to da Vinci clients on October 13, 2011, informing that the devices were not cleared for thyroidectomy indication. However, the company did not report this too to the regulator. The agency noted that Intuitive received 13 complaints and filed 5 MDRs related to thyroidectomise performed with the devices.
Intuitive also sent out another letter in October 2011 to da Vinci clients with information for inspection of instrument cannulas, proper flushing of instruments and proper transportation of the devices, but did not report this action to the regulator.
Intuitive sent another letter to da Vinci clients on January 24, 2013, clarifying the types of patients and conditions for which its devices were indicated. The new version of the IFU warned that da Vinci transoral surgery or TORS is not indicated for pediatric patients. The FDA noted that the vagueness in the previous version of the IFU represented a health risk to pediatric patients.
The Form 483 is a notice that informs a company about possible violation of federal regulations that are found by FDA inspectors. These are inspectional observations and do not represent a final determination by the agency regarding compliance.
ISRG closed Tuesday's regular trading session at $501.70, down $2.47 or 0.49 percent on a volume of 167,119 shares. In after-hours, the stock further declined $10.99 or 2.19 percent to $490.71.
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by RTT Staff Writer
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