FDA 483 - Karl Storz Endovision, Inc. - September 17, 2021

An FDA inspection of Karl Storz Endovision, Inc. in Charlton, MA, a medical device manufacturer, revealed significant deficiencies in design control processes. The firm failed to establish a design history file for its 11101VNS Strobo-Video-Rhino-Laryngoscope, lacked adequate design change procedures, and did not properly verify design outputs against input requirements. These issues are serious as they are linked to complaints of operator burns and high heat associated with the device.