Illinois surgical devices maker Instrumed GmBH is in the FDA’s cross-hairs after agency investigators turned up a slew of manufacturing violations during a July 2013 inspection of the company’s German facility.
Despite a September 2013 response from Instrumed CEO Forrest Whittaker, the FDA maintained that the company had not properly addressed regulators’ concerns, including lack of warning labels on electrodes that the FDA said were associated with patient injuries.
"The [Instructions for Use] for Right Angle Electrodes from your contract manufacturer includes a voltage warning stating that any voltage exceeding 650Vp could lead to tissue damage. Right Angle Electrodes are included as part of your firm’s finished device. However, the IFU included in the finished device does not have the voltage warning," according to the FDA warning made public this month. "According to your firm’s complaint record, 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". However, your firm design validation failed to consider the conditions similar to those that are expected to be experienced in the user environment, the actual conditions of use, or how the lack of explicit instructions could lead to device malfunction or injury to the patient."
The FDA inspectors listed a slew of additional violations, including failure to properly act on reports of insulation damage and cracking issues in laparoscopic devices; failure to document efforts to mitigate issues with cracking suction tubes; failure to investigate complaints to determine whether a follow-up investigation was necessary; and others.
The federal watchdog agency cited 14 issues in total, and further listed 25 Instrumed devices that the FDA said need additional documentation to demonstrate that they’re allowed on the U.S. market. The agency said that Instrumed hadn’t properly demonstrated that the devices were truly pre-amendment devices that were "grandfathered" from 510(k) and premarket approval requirements.
The FDA plans to follow-up with another inspection to ensure that the company follows through with its corrective actions, according to the warning letter.