- Dozens of injuries involving operations in which Intuitive Surgical's (ISRG) da Vinci robotic surgery system was used weren't reported for years, if at all, a Bloomberg review has found.
- "The adverse event reporting system is a disaster," says David Challoner of the University of Florida. "Every link in the chain has a reason not to report."
- Intuitive spokeswoman Angela Wonson said that any time gap between an injury occurring and the reporting of the problem is often because the company doesn't find out about it until it's sued. In most cases, "there was no complaint at the time of the surgery or in the weeks thereafter by the patient, surgeon or hospital," Wonson said. She added that adverse event reports don't necessarily mean that the da Vinci is to blame.
Injuries involving Intuitive device under-reported
Dec 30 2013, 07:29 ET