The Food and Drug Administration (FDA) is alerting providers about a voluntary recall of Fujifilm’s duodenoscope model ED-530XT due to health risks associated with improper reprocessing of the device.
The ED-530XT duodenoscope — used to observe the esophagus, stomach, and duodendum — has a complex design that could make cleaning and sterilizing the device difficult. Fujifilm will replace the affected parts and send users new operation manuals that prescribe an annual device inspection and recommend that customers precondition the duodenoscope at specific temperature and humidity levels during reprocessing.
Fujifilm urges customers to:
- complete and return a Field Action Verification form acknowledging this notice and listing the serial numbers of any affected duodenoscopes; and
- remove and replace old operation manuals after receiving new ones.
Fujifilm will contact all customers by October for replacement parts and loan customers duodenoscopes to use during the replacement period.
FDA advises health care professionals to report instances of bacterial contamination in duodenoscopes to the agency’s MedWatch Safety Information and Adverse Event Reporting Program.
Contact Director of Policy Erin O’Malley at firstname.lastname@example.org or 202.585.0127 with questions.