Karl Storz Endoscopy America Inc – FDA 483, May 24, 2022

An FDA inspection of Karl Storz Endoscopy America Inc. in Auburn, MA, revealed significant deficiencies in medical device reporting and corrective and preventive action procedures. The firm failed to submit numerous Medical Device Reports (MDRs) within 30 days for events involving serious injury or death, and its recall process for nonconforming endoscopes was found to be inadequate, lacking proper notification and control over affected products.