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Pentax Voluntarily Recalls ED-3490TK Video Duodenoscopes for Design and Labeling Changes

Pentax will replace the forceps elevator mechanism, O-rings and the distal end covering.

Published: February 9, 2018

VOLUNTARY RECALL Pentax will make design and label changes to the ED-3490TK Video Duodenoscope.

Pentax Medical is voluntarily recalling all ED-3490TK video duodenoscopes so that it can make design and labeling changes that the company says will make it easier to effectively clean and disinfect the scopes, which have been the subject of several recalls over patient-to-patient infections associated with inadequate reprocessing.

Pentax will replace the forceps elevator mechanism, O-rings and the distal end covering, according to a customer letter. The design changes are intended to reduce the chance of patient fluids leaking into the closed elevator channel under the distal cap during use, says the company.

Pentax has also updated the operation manual to recommend periodic inspection of the forceps elevator mechanism. "Meticulous cleaning of the elevator recesses and attention to following all reprocessing instructions are required," says the FDA, which last week cleared the updated design and labeling changes for the ED-3490TK.

Duodenoscopes are complex instruments that contain many small working parts. If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient. The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions "to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes."

The recall letter includes a field correction response form that customers should fill out and return. It lists the serial numbers of the recalled duodenoscopes, which Pentax will then arrange to have returned so it can make the design updates beginning in April. It will take 5-7 days to update and ship the scopes back to customers, says Pentax. You may use your ED-3490TK until you are contacted to update the scope, says the company.

JoEllen McBride, PhD

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