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Robotic Surgery Complications Going Underreported
First time accepted submitter neapolitan writes "PBS has a report on the difficulties of tracking the complications arising from surgical robotic systems, particularly the Da Vinci robotic surgery apparatus. The original study (paywall) notes that there is a large lag in filing reports, and some are not reported at all. It is difficult to assess the continued outcomes and safety without accurate reporting data."
I write these reports and analyze medical device complaints for a living. There is a legal responsibility to report any death or serious injury involving a medical device to the FDA within 30 days (5 days for very serious malfunctions) of the Become Aware date. That's the date that the reporter became aware there was an incident. This is filed on an Medical Device Report (Form 3500A). Both the users and manufacturers are responsible for reporting with the manufacturer having an obligation to investigate each reportable event and file an investigative conclusion (Follow up) if the investigation is not completed on the first report. The FDA audits medical device manufacturers on a regular basis (yearly, bi-annually, or for cause) and any missed reports found in the manufacturers records are automatic observations (483). A failure to respond to the observations can result in a Warning Letter. Further failure to respond leads to the Justice dept. getting involved and potential device seizure, manufacturing stoppage, and corporate shut down actions (Consent decree). An individual caught hiding info or being untruthful can face permanent black listing from ever working in a medical or medical device manufacturing profession for the rest of their life.