PMI Cited for Not Reporting Malfunctioning Devices, Deaths

Power Medical Interventions (PMI) did not follow medical device reporting (MDR) regulations after learning that its malfunctioning devices could have contributed to patient deaths, according to an FDA warning letter. MDRs were not submitted to the FDA in a few instances in which one of the company’s cutting and stapling devices malfunctioned during surgery, the letter says. In its response, PMI described the actions it had taken, or intended to take, to address each of the inspectional observations, according to a company statement. The FDA acknowledges the responses, adding that it will verify compliance at a future inspection. See letter at http://www.fda.gov/foi/warning_letters/s6998c.htm
Devices & Diagnostics Letter