Some Fuji Duodenoscopes Pulled From Market

FujiFilm Medical Systems, USA Endoscopy Division (“FMSU-ESD”) declared this week that it is removing some of its older model duodenoscopes from the market. According to FujiFilm, the ED-250XL5, ED-250XT5, ED-450XL5, and ED-450XT5 model duodenoscopes are the models that are being recalled.

Per a press release from FujiFilm, which can be found here:

“These devices are indicated for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. After discussions with the U.S. Food and Drug Administration, FMSU-ESD has made a business decision to replace these older duodenoscope models with the currently marketed model, the ED-530XT. This removal will result in the exclusion of these legacy models from the scope of the FDA 522 order. As a result of this product removal, FMSU-ESD is hereby requesting the return of all 250 and 450-series model duodenoscopes from your facility.

FMSU-ESD will replace all returned units with a new ED-530XT, along with required accessories, at no cost to you. Alternatively, reasonable reimbursement for the return of the duodenoscopes may be provided to you.”

Duodenoscopes have of course been closely linked to many of the superbug outbreaks in the US over the last several years. This press release by Sarah Faulkner at Mass Device provides further details about duodenoscopes and their recent history:

“Duodenoscopes are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into a patient’s throat. More than 500,000 ERCPs using the scopes are performed annually in the U.S.

In February and March 2015, inadequately-cleaned duodenoscopes were tied to deadly suberbug outbreaks in hospitals in Connecticut, Virginia, California and Washington. The scopes associated with the infectious outbreak were made by Olympus (TYO:7733) and Hoya‘s (TYO:7741) Pentax subsidiary. No deaths have occurred in association with Fujifilm’s duodenoscopes.”

Read the entire article here: Fujifilm pulls older duodenoscopes after superbug outbreaks

We at Mobile Aspects have seen usage of duodenoscopes drastically reduced or even stopped over the past few years due to the linkage with the superbug outbreaks. We expect that this will be standard operating procedure across many facilities until clearer guidance is received from the FDA and the endoscope manufacturers.