Surgical Robot Manufacturer da Vinci Failed to Report; Notified Patients Before FDA
In medical device news, the FDA says da Vinci failed to tell the agency of complaints and “corrective actions” taken, yet sent doctors a letter with suggestions and recommendations in October of 2011. In a July 9 statement, Intuitive indicated it “takes regulatory obligations seriously and has implemented corrective actions for all the FDA’s observations.”
Over 450,000 people had robot-assisted surgery this past year, but problems with the device has prompted investigations- and lawsuit filings- on behalf of injured patients.
In ongoing investigation and reporting, CNBC posted the following on June 25, 2013 and produced an extensive documentary on the da Vinci system.
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by Herb Greenberg, CNBC Senior Stocks Coordinator
The Food and Drug Administration says Intuitive Surgical, which makes the da Vinci surgical robot, broke procedures when it warned customers about problems with the robot without first alerting regulators.
In what is known as a “483” letter following a recent inspection the FDA said that between January 2010 and December 2011 Intuitive received 134 complaints and filed 83 medical device reports related to “tip cover issues.”
According to the FDA, in October 2011 Intuitive sent customers a letter 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.”
The “correction,” the FDA said, was in response to complaints regarding “arcing through damaged tip covers that caused patient injury.”
Arcing occurs when electrical currents jump inside someone during a surgery. Arcing was a focus of CNBC’s Investigations Inc.’s documentary, “The da Vinci Debate.”
An FDA 483 letter is a notice to a company that FDA inspectors have found a possible violation of federal regulations. The letters are not a final determination by the agency. The company can respond to and contest the findings of such letters.
In a statement issued to CNBC Tuesday, Intuitive said the corrective letter it sent to customers during the period cited by the FDA “was a reiteration of existing FDA-cleared labeling that reminded users on proper use. The observation is that we didn’t report that we sent the letter. We documented it as a non-reportable field action to the FDA because it did not change any of the FDA cleared labeling. Over the last several years, we have maintained consistent and ongoing communication with the FDA to include tip cover.”
Da Vinci Surgical Robot Maker Failed To Report Complaints, Corrections, FDA Says
ALAMEDA, Calif. — The maker of the da Vinci surgical robot failed to tell the Food and Drug Administration about complaints and corrective actions, the agency says in a May 30 inspection report.
The FDA says that between January 2010 and December 2011, manufacturer Intuitive Surgical Inc. received 134 complaints and filed 82 Medical Device Reports (MDRs) related to arcing from damaged tip covers that caused patient injury. The agency says that in October 2011, Intuitive sent a letter to doctors with suggestions and recommendations, but did not report that action to the FDA.
Between July 2009 and October 2011, the FDA says Intuitive received 13 complaints and filed five MDRs about the device being used to preform thyroidectomies. The FDA says that in October 2011, Intuitive sent out a letter that the da Vinci system was not cleared for thyroidectomies, but failed to tell the FDA about the letter.
The FDA said Intuitive promoted the da Vinci system for thyroidectomies in a letter.
Intuitive failed to report that there were five MDRs associated with an October 2011 field action related to thyroidectomies, the agency says. It says the manufacturer reported zero MDRs, but during an inspection, five MDRs were found to be related to the field correction.
In a July 9 statement, Intuitive said it takes its regulatory obligations seriously and has implemented corrective actions for all the FDA’s observations.
The company said its field actions were reclassified as reportable by the FDA and were posted on the agency’s website on May 29 as recalls.
Intuitive said the five MDRs that were not listed on the field action report were “non device related” MDRs that were previously reported to the FDA but not in the field action report. “We have corrected this omission,” the company said.
The company also said it has implemented a procedure and detailed instructions for adding new uses.
The da Vinci robot is the subject of personal injury lawsuits. In June, a Washington state court jury returned a defense verdict in the first case to go to trial.