FDA EIR - Karl Storz Endoscopy - August 20, 2020

An FDA inspection of Karl Storz Endoscopy America Inc. (FEI: 3007475226) took place on August 20, 2020, at their El Segundo, CA facility. This was a risk-based inspection focusing on the firm's post-market activities for laparoscopic insufflators, specifically reviewing complaint handling, Medical Device Reports (MDRs), and Corrective and Preventive Actions (CAPAs). The El Segundo site functions as a centralized customer service and complaint processing hub for North America, not a manufacturing or distribution facility for these devices. The inspection followed regulatory guidelines for medical device manufacturers and assessed compliance with Quality System (QS) and Medical Device Reporting (MDR) regulations, including 21 CFR Part 11 for their complaint database.

The firm had received 173 laparoscopic insufflator complaints and submitted 2 MDRs since July 2018. A CAPA was initiated to address common issues like "Does Not Work/Not Working Properly." Notably, no objectionable conditions were observed during the inspection, and no FDA-483 (Inspectional Observations) was issued. The report indicated that Karl Storz Endoscopy America Inc. demonstrated effective management of complaints and MDRs for the reviewed product lines. An ongoing voluntary recall related to insufflator tubing, manufactured by a different entity, was also noted.