Intuitive Surgical (NSDQ:ISRG) shares dropped in after-hours trading and opened down 0.8% today after an FDA report accused the medical device company of failing to report injuries and warning to customers on its da Vinci surgical robot.
The FDA’s Form 483 report, stemming from inspections of the Sunnyvale, Calif.-based company’s plant in April and May, says Intuitive told customers in October 2011 how to avoid electrical arcing in patients due to cracked tip covers.
"On 10/10/2011, Intuitive Surgical Inc. sent out a letter to da Vinci clients with suggestions and recommendations for the proper use of instruments with tip covers and for the correct generators that should be used with monopolar instillments. This action was not reported to the San Francisco District Recall Coordinator," according to the FDA report. "This correction was in response to complaints and [medical device reports] for arcing through damaged tip covers that caused patient injury. Between January 2010 and December 2011, Intuitive Surgical Inc. received 134 complaints and filed 82 MDRs related to tip cover issues."
The federal watchdog agency also flagged Intuitive for a letter sent that same month telling clients that the da Vinci system is not cleared for thyroidectomies, according the Form 483.
"On 10/13/2011, Intuitive Surgical Inc. sent out a letter notifying da Vinci clients that the da Vinci surgical systems are not cleared tor thyroidectomy indication. This action was not reported to the San Francisco District Recall Coordinator," the FDA investigator wrote. "Between July 2009 and October 2011, Intuitive Surgical received 13 complaints and filed 5 MDRs related to thyroidectomies performed with the da Vinci system."
The FDA also said Intuitive failed to let the FDA know about the 5 MDRs stemming from the thyroidectomy notification.
"The 806 report No. 2955842-101311-004 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. Intuitive Surgical Inc. failed to report these 5 MDRs on the 806 report provided to the San Francisco District Coordinator on 04/11/2013," the FDA investigator wrote.
ISRG shares slipped 2.2% yesterday in after-hours trading to $490.71 apiece. Intuitive shares were trading at $508.34 each as of about 10:20 this morning, adding 1.3% to yesterday’s $501.70 closing price.