Study Finds An Underreporting of Injuries Associated With Defective Medical Devices

January 21, 2014

Advancements in the field of technology within the medical industry, such as the use of robotics in surgery, have gained significant ground in recent years.

The Defective Medical Device Attorneys with the law firm of Ferrer, Poirot & Wansbrough point out though, new studies have shown using this new technology may be putting patients at a greater risk of harm than previously believed.

According to Bangor Daily News, researchers have found the instances of patients being injured during robotic surgery may be significantly underreported. The team found that incidents of injury and death are supposed to be reported to the U.S. Food and Drug Administration, but an examination of records showed numerous cases that were missing and others containing incomplete data.

A fine example of these problems was seen in the reporting associated with da Vinci Surgical Robot Injuries. The device has been used to perform roughly 350,000 procedures, which resulted in 3,697 reports of injuries or deaths associated with the device being reported. Experts have shown though, several documented cases were not included in these numbers.

Officials say the problem stems from a dependence on post-market studies to determine safety of a product, rather than putting devices through rigorous testing prior to public release to the market.

These issues are why those who have been harmed by a defective medical device should pursue holding manufacturers accountable and responsible for the harm their products cause.