FDA EIR - Karl Storz Endovision, Inc. - September 17, 2021

An FDA inspection of Karl Storz Endovision, Inc., a medical device manufacturer in Charlton, MA, was conducted from August 24 to September 17, 2021. The inspection primarily focused on the company's Class II electro-mechanical products and endoscopes, particularly the 11101 VNS Strobo-Video-Rhino-Laryngoscope. This inspection followed up on previous findings from 2018 and reviewed aspects like management controls, corrective and preventive actions, production, process controls, and design controls. The inspection resulted in a three-item FDA 483, identifying significant violations of medical device quality system regulations. Key issues included the absence of a complete design history file for the 11101 VNS Strobo-Video-Rhino-Laryngoscope, indicating a failure to adhere to established design plans and regulatory requirements. This was noted as a repeat observation. Furthermore, the company's procedures for managing design changes were found inadequate, as Engineering Change Orders for device modifications lacked proper verification and validation. Additionally, design verification testing was insufficient. Specifically, leak testing for the 11101 VNS model was performed on a prototype with undefined specifications, and critical sterilization compatibility testing at maximum temperature was omitted after initial failures. The firm also failed to conduct temperature rise testing for the device when used with various recommended light sources, despite receiving complaints of operator burns and high heat. Management acknowledged the observations and committed to providing a formal response to the FDA within 15 business days, outlining corrective actions to address these serious deficiencies.