FDA Issues Urgent Notice to Healthcare Providers Following Endoscope Recall

By MedTech Intelligence Staff
April 5, 2022


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, Quality Management, RC - Medical Device Labeling, Regulatory

Last week Karl Storz issued an urgent medical device recall notice for specific flexible urological endoscopes, providing a labeling update and advising against certain sterilization methods. The labeling update corrects the instructions for use and states that high-level disinfection and liquid chemical sterilization should not be used as reprocessing methods. Validation testing of these methods revealed that the “required efficacy level of disinfection was not achieved”, and as a result, a “patient may be exposed to a higher risk of infection,” according to the notice.

Karl Storz provided specific instructions for device users and healthcare providers, but considering the level of risk, FDA also issued a letter to healthcare providers yesterday to ensure they are aware of the issue.

Providers that cannot sterilize the endoscopes via the methods described in the updated instructions for use are urged to return the affected endoscopes.

Last year FDA announced an investigation into more than 450 medical device reports—dated between January 1, 2017 and February 20, 2021—that cited patient infections and contamination issues associated with reprocessed urological endoscopes. The agency identified Karl Storz and Olympus Corp. as the manufacturers of the devices named in the MDRs.