June 11, 2014 — The Illinois-based medical device manufacturer Instrumed has received a Warning Letter from the U.S. Food and Drug Administration (FDA) for failing to address serious issues that were discovered at a facility in Germany.
The problems for Instrumed began after an inspection from the FDA in July 2013. Instrumed responded two months later. In March, the FDA warned the company that they failed to address safety concerns. That warning letter was made public this week.
The warning letter cites 14 violations, including a problem with high-voltage electrodes that has been linked linked to one patient’s injury. Specifically, the manufacturer of the electrode provides warnings about any voltage exceeding 650V could cause patient injury. However, products sold by Instrumed lack these warnings.
According to the FDA:
“The lack of warning has led to users using the product at a high voltage, causing melting or tip damage and, in some cases, patient injury. Your firm’s classified these complaints as ‘user error.’”
The FDA also found that Instrumed failed to adequately address all customer complaints. For example, after the company received complaints about laparoscopic devices with insulation and cracking problems, Instrumed failed to initiate a corrective action. The company also failed to appropriately document actions taken to correct cracking on Frazier and Baron suction tubes.
Instrumed manufactures laparoscopes, surgical clamps, vascular and thoracic suction tubes, surgical knives, and vascular wire retractors. The FDA found that 25 devices do not have adequate documentation to prove that they are “grandfathered” into the current approval system.
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