Washington DCA new study suggests that reporting of da Vinci robot injuries to the US Food and Drug Administration is low, meaning the agency is not aware of all the injuries, including deaths, linked to the da Vinci robot, or is not made aware of them in a timely manner. Meanwhile, da Vinci lawsuits have been flied, alleging patients have been harmed by the use of the surgical robot.
The study appeared in the Journal for Healthcare Quality (online 8/27/13), and involved researchers analyzing reports of complications linked to robotic surgery. (Included in the study were reports to the FDA, LexisNexis and PACER from January 1, 2000, to August 1, 2012). Reports from LexisNexis and PACER were cross-referenced with the FDA database to see where reports were filed inaccurately, late or not at all.
Researchers found that there were 245 serious events reported to the FDA linked to the surgical robot. Of those, 71 were reports of death and 174 involved nonfatal injuries. Reports were generally made to the FDA in about 30 days of the adverse event, although the longest report was not filed for 930 days. There were also eight improperly filed cases, including five in which no report was made to the FDA. In situations where a report was filed late, the average time to the report being made was 20.4 months.
Regulations require medical device manufacturers and hospitals to report every death and serious injury linked to the device to the FDA within 30 days of learning about an incident.
“It is important that the true incidence of complications with robotic-assisted laparoscopic surgery be known to ensure continued safe innovation,” researchers wrote.
Lawsuits have been filed against Intuitive Surgical, alleging patients were harmed by the use of the da Vinci surgical robot. One such lawsuit was filed in the Eastern District of Pennsylvania, alleging a patient suffered injuries as a result of complications from prostate cancer surgery using the robotic device. Among the alleged injuries were bleeding, bladder spasms, nerve damage and bladder blockage, according to The Pennsylvania Record (8/21/13). Also named in the lawsuit (federal case number 2:13-cv-048140WY) are Thomas Jefferson University Hospital, Jefferson University Physicians and Jefferson Urology Associates.
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