Failure to Report Malfunctions, Deaths Leads to FDA Warning

The U.S. Food and Drug Administration has issued a warning letter to Power Medical Interventions for not following medical device reporting regulations after learning malfunctioning devices may have contributed to deaths and injuries of patients. 

The Langhorne, Pa.-based company also was cited for failure to evaluate the cause of the injuries/deaths and failure to conduct studies to ensure that its devices “conform to defined user/patient needs and intended uses.” 

The firm, which makes surgical cutting and stapling devices, did not submit regulations to the FDA after learning of instances in which its devices malfunctioned during surgery, possibly causing or contributing to the death or serious injury of patients, the letter says. 

To view the warning letter, visit www.fda.gov/foi/warning_letters/s6998c.htm.