FDA 483 - Karl Storz Endovision, Inc. - June 14, 2022

An FDA inspection conducted at Karl Storz Endovision, Inc. from May 3 to June 14, 2022, revealed a significant observation regarding the company's risk management practices. The primary issue cited in the FDA Form 483 was the inadequacy and incompleteness of risk analysis, specifically concerning the T-Luer feature on certain flexible endoscopes, including the 11278VSUE Flexible Video-Uretero-Renoscope and 11000BC1 Bronchoscope. The FDA noted that the Design History Files for these devices lacked a comprehensive risk analysis for the T-Luer feature, despite it being identified as a factor contributing to device-associated infections due to its complex design and tendency to retain debris. This deficiency is particularly critical as the T-Luer feature has been subject to a recall because it fails to achieve adequate microorganism reduction following high-level disinfection. Karl Storz Endovision's own procedure for Product Risk Management requires such analyses for new product designs. However, firm management acknowledged that a T-Luer specific risk analysis was not performed. Issued under the Federal Food, Drug and Cosmetic Act, the 483 implies that the company must undertake corrective actions to ensure proper risk assessment and documentation for their medical devices, bringing their quality system into full compliance with regulatory expectations and their internal procedures.