• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Fujifilm pulls older duodenoscopes after superbug outbreaks

Fujifilm pulls older duodenoscopes after superbug outbreaks

January 13, 2017 By Sarah Faulkner

Fujifilm pulls older duodenoscopes after superbug outbreaksFujifilm Holdings (TSE:4901) said today that it will pull its legacy 250/450 duodenoscope models from clinical use and replace those devices with the ED-530XT model at no cost to its customers.

The company said in a letter to its customers that the decision is not directly related to any safety concerns and that it has not received any recent reports of adverse events associated with the scopes.

The FDA is continuing to investigate the link between reprocessed endoscopes and the transmission of infectious agents by working with duodenoscope manufacturers as they incorporate new techniques to adequately disinfect the devices.

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.

Following the outbreak, the FDA published warning letters that it sent to the endoscope makers, warning them about violations that the federal watchdog found during spring inspections at plants located in the U.S. and Japan.

In December 2015, the FDA cleared FujiFilm’s revised manual reprocessing instructions for its ED-530XT duodenoscope, replacing reprocessing instructions included on the original device label.

Filed Under: Endoscopic, Food & Drug Administration (FDA), Hospital Care, Regulatory/Compliance, Wall Street Beat Tagged With: Fujifilm

More recent news

  • Omnipod 5 rollout for type 2 rolls on as Insulet pursues next-gen automation
  • Ancora Heart reaches enrollment milestone in pivotal heart failure device trial
  • PharmaSens, SiBionics innovatively combine tech in all-in-one insulin patch pump
  • Johnson & Johnson launches daily disposable multifocal toric contact lens
  • Study backs Biolinq intradermal sensor in muscle loss prevention during GLP-1 therapy

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy