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

An FDA inspection of Karl Storz Endovision, Inc. in Charlton, MA, revealed a significant deficiency in their risk analysis procedures. The firm failed to conduct adequate and complete risk analyses for flexible endoscopes utilizing the T-Luer feature, despite this feature being identified as a factor in device-associated infections and subject to an ongoing recall. This indicates a serious lapse in design control and product risk management.