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 said.

The FDA cited PMI for failing to “review, evaluate and investigate any complaints involving the possible failure of a device to meet any of its specifications.”

In addition, PMI was reprimanded for its complaint handling procedures. The FDA said those procedures “have not been implemented to ensure that all complaints are processed in a uniform and timely manner.”

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.

The FDA’s warning letter is accessible at: http://www.fda.gov/foi/warning_letters/s6998c.htm

SOURCE: Staff and wire reports