June 11, 2014 — The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Instrumed, an Illinois-based medical device company, after the company failed to fix problems identified in inspections of a German facility last year.
The warnings stemmed from an inspection that occurred in July 2013. Instrumed responded in September 2013, but the FDA said that the company had not properly addressed their concerns. The warning letter was issued in March and recently made public.
One problem was a lack of warnings on electrodes, which the FDA said were associated with injuries. Specifically, the Instructions for Use for Right Angle Electrodes from Instrumed’s contact manufacturer includes a voltage warning stating that any voltage exceeding 650V could lead to tissue damage. Certain devices sold by Instrumed do not include 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.’”
Other problems cited by the FDA included failure to correct problems after receiving complaints about laparoscopic devices with insulation damage and cracking issues. The FDA was concerned that the company failed to appropriately document corrective action regarding Frazier and Baron suction tubes that were cracking due to poor attachment.
In total, the FDA cited 14 issues and listed dozens of devices that do not have adequate documentation showing that they are allowed on the market. The FDA is requesting immediate action to submit 510(k) applications that will bring the devices into compliance.
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