Fujifilm Medical Warned for Serious Postmarket Surveillance Failures

The FDA issued a warning letter to Fujifilm Medical Systems for failure to conduct postmarket surveillance on its duodenoscope model, which posed significant adverse health consequences.

The Stamford, Connecticut-based firm was instructed to conduct postmarket surveillance in October 2015 because device failures were likely to cause disease and possibly death. It failed to comply with the order and address the agency’s concerns regarding how duodenoscopes are reprocessed in real-world settings.

The FDA requested that the firm submit a plan outlining how it will process half of all samples of the misbranded device by Aug. 31, 2018, and finish the processing by Dec. 31.