by
John R. Fischer, Senior Reporter | February 19, 2024
The agency addressed these issues in a 2014 warning letter that said the company notified customers about how to use the tip covers but violated federal regulations by not reporting the issue to the FDA. Intuitive recalled the tip covers and the FDA said in a follow-up letter that it had satisfied its requirements for addressing the violations.
A financial report it filed with the Securities and Exchange Commission at the time said that it was facing 93 suits filed by plaintiffs that "allege that they or a family member underwent surgical procedures that utilized the da Vinci Surgical System and sustained a variety of personal injuries and, in some cases, death as a result of such surgery.”
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Since then, the da Vinci has been connected to thousands of injuries and over 200 deaths, as revealed in the NBC investigation.
Intuitive did not
respond to NBC News for comment. Jack Scarola, who is representing Harvey Sultzer, said neither he nor his client had any comment beyond the allegations in the suit.
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