Karl Storz Endoscopy – FDA EIR, Apr 16, 2018

An FDA routine Level 1 Quality System Inspection Technique (QSIT) inspection was conducted at Karl Storz Endoscopy America Inc., located in El Segundo, CA, on April 16, 2018. This one-day inspection focused on the firm's role as a Complaint File Establishment for various Class II medical devices, specifically the Calculase II laser and Extracorporeal Shockwave Lithotripter (ESWL) X-ray systems. The scope included an assessment of the company's Corrective and Preventive Action (CAPA) system, complaint handling processes, and Medical Device Reporting (MDR) activities, in accordance with regulatory frameworks governing medical devices, including adherence to 21 CFR Part 11 for their complaint system. Karl Storz Endoscopy America Inc. serves as the North American headquarters, responsible for processing complaints, MDRs, CAPAs, and recalls for products marketed in the U.S. and Canada. Importantly, the inspection concluded with no objectionable conditions observed regarding the firm's management of complaints and MDRs. Consequently, no FDA-483, indicating observations of non-compliance, was issued. This outcome signifies that the company's reviewed quality system elements met regulatory expectations at the time of inspection, and therefore, no specific required actions were mandated by the FDA.