Fujifilm Medical Systems U.S.A., Inc. failed to investigate complaints about a device failure, establish procedures for evaluating complaints and taking corrective and preventive action, fail report a correction or removal, and adequately validate a process, according to a Form 483.
The inspector first observed that Fujifilm did not review, evaluate, and investigate complaints involving the possible failure of its duodenoscopes to meet any of their specifications.
Second, the Form 483 says that procedures for receiving, reviewing, and evaluating complaints by a formally designated unit were not adequately established. Specifically, Fujifilm did not conduct a medical device report review for work orders generated for repairing returned duodenoscopes that had malfunctioned.
The inspector also observed that Fujifilm did not establish procedures for corrective and preventive action for returned duodenoscopes.
Fourth, the inspector found that the firm did not report a correction or removal that was conducted to reduce a health risk posed by a duodenoscope.
For example, one complaint stated that a duodenoscope’s suction button became stuck during a procedure, causing a delay. Fujifilm took corrective action but did not submit a field correction report.
Finally, the Form 483 says the company failed to adequately validate a duodenoscope cleaning process whose results cannot be fully verified by subsequent inspection and testing.