• Skip to primary navigation
  • Skip to main content
  • Skip to footer

SAGES

Reimagining surgical care for a healthier world

  • Home
    • Search
    • SAGES Home
    • SAGES Foundation Home
  • About
    • Who is SAGES?
    • SAGES Mission Statement
    • Advocacy
    • Strategic Plan, 2020-2023
    • Committees
      • Request to Join a SAGES Committee
      • SAGES Board of Governors
      • Officers and Representatives of the Society
      • Committee Chairs and Co-Chairs
      • Full Committee Rosters
      • SAGES Past Presidents
    • Donate to the SAGES Foundation
    • SAGES Store
    • Awards
      • George Berci Award
      • Pioneer in Surgical Endoscopy
      • Excellence In Clinical Care
      • International Ambassador
      • IRCAD Visiting Fellowship
      • Social Justice and Health Equity
      • Excellence in Community Surgery
      • Distinguished Service
      • Early Career Researcher
      • Researcher in Training
      • Jeff Ponsky Master Educator
      • Excellence in Medical Leadership
      • Barbara Berci Memorial Award
      • Brandeis Scholarship
      • Advocacy Summit
      • RAFT Annual Meeting Abstract Contest and Awards
    • “Unofficial” Logo Products
  • Meetings
    • NBT Innovation Weekend
    • SAGES Annual Meeting
      • 2024 Scientific Session Call For Abstracts
      • 2024 Emerging Technology Call For Abstracts
    • CME Claim Form
    • Industry
      • Advertising Opportunities
      • Exhibit Opportunities
      • Sponsorship Opportunities
    • Future Meetings
    • Related Meetings Calendar
  • Join SAGES!
    • Membership Benefits
    • Membership Applications
      • Active Membership
      • Affiliate Membership
      • Associate Active Membership
      • Candidate Membership
      • International Membership
      • Medical Student Membership
    • Member News
      • Member Spotlight
      • Give the Gift of SAGES Membership
  • Patients
    • Healthy Sooner – Patient Information for Minimally Invasive Surgery
    • Patient Information Brochures
    • Choosing Wisely – An Initiative of the ABIM Foundation
    • All in the Recovery: Colorectal Cancer Alliance
    • Find a SAGES Member
  • Publications
    • SAGES Stories Podcast
    • SAGES Clinical / Practice / Training Guidelines, Statements, and Standards of Practice
    • Patient Information Brochures
    • TAVAC – Technology and Value Assessments
    • Surgical Endoscopy and Other Journal Information
    • SAGES Manuals
    • SCOPE – The SAGES Newsletter
    • COVID-19 Annoucements
    • Troubleshooting Guides
  • Education
    • Wellness Resources – You Are Not Alone
    • OpiVoid.org
    • SAGES.TV Video Library
    • Safe Cholecystectomy Program
      • Safe Cholecystectomy Didactic Modules
    • Masters Program
      • SAGES Facebook Program Collaboratives
      • Acute Care Surgery
      • Bariatric
      • Biliary
      • Colorectal
      • Flexible Endoscopy (upper or lower)
      • Foregut
      • Hernia
      • Robotics
    • Educational Opportunities
    • HPB/Solid Organ Program
    • Courses for Residents
      • Advanced Courses
      • Basic Courses
    • Fellows Career Development Course
    • Robotics Fellows Course
    • MIS Fellows Course
    • Facebook Livestreams
    • Free Webinars For Residents
    • SMART Enhanced Recovery Program
    • SAGES OR SAFETY Video
    • SAGES Top 21 MIS Procedures
    • SAGES Pearls
    • SAGES Flexible Endoscopy 101
    • SAGES Tips & Tricks of the Top 21
  • Opportunities
    • NEW-Area of Concentrated Training Seal (ACT)-Advanced Flexible Endoscopy
    • SAGES Fellowship Certification for Advanced GI MIS and Comprehensive Flexible Endoscopy
    • Multi-Society Foregut Fellowship Certification
    • SAGES Research Opportunities
    • Fundamentals of Laparoscopic Surgery
    • Fundamentals of Endoscopic Surgery
    • Fundamental Use of Surgical Energy
    • Job Board
    • SAGES Go Global: Global Affairs and Humanitarian Efforts
  • Search
    • Search All SAGES Content
    • Search SAGES Guidelines
    • Search the Video Library
    • Search the Image Library
    • Search the Abstracts Archive
  • OWLS
  • Log In

Ambu® aScope Duodeno

August 19, 2020 by Jorge Humberto Rodriguez Quintero

Authors: Jorge Humberto Rodríguez-Quintero, MD and David M Pechman, MD

Ambu® received FDA approval for aScopeTM Duodeno on July 17th, 2020.

The Ambu® aScopeTM Duodeno is a single-use duodenoscope for endoscopic retrograde cholangiopancreatography (ERCP) procedures.  It was approved by the FDA along with its reusable processor video unit, the Ambu® aBoxTM Duodeno.  The device was created to address the ongoing concern regarding cross-contamination with reusable endoscopes and it is one of two devices approved by the FDA as a fully disposable duodenoscope. This is in contrast to other similar FDA-approved products which offer disposable endcap only.

The aScopeTM Duodeno is lightweight and is ergonomically designed with a rippled-surface handle for improved comfort during prolonged procedures. The design is similar to conventional duodenoscopes to ensure seamless transition for users. The device features controls for lens washing, insufflation, and sunction and standard remote switches for image freezing and capture. The aScopeTM Duodeno offers high definition imagery, flexible bending angles, and precise elevator functionality to allow for successful navigation of the GI tract and access to the biliary system. The device has an outer diameter of 13.7mm and a working channel of 4.2mm.

In 2015, the FDA started to conduct post-market surveillance studies to evaluate the percentage of duodenoscopes that remained contaminated after following standard reprocessing instructions. Preliminary results showed higher than expected levels of contamination with 3.6% of positive cultures for low to moderate risk organisms and up to 5.4% for higher risk organisms such as E.coli and Pseudomonas aeruginosa. FDA analysis of 205 medical device reports revealed 45 reports of patient infection, one report of patient exposure, and 159 reports of device contamination. Three deaths were at least partially attributed to the use of contaminated duodenoscopes. The center for Medicare & Medicaid Services recently announced a new transitional pass-through payment category for single-use endoscopes, recognizing how these devices are important for improving patient safety.

The aScopeTM Duodeno has been determined to be substantially equivalent and perform as well as or better to predicate devices such as the Olympus TJF-Q180V (K143153) – EVIS EXERA II Video system. (K100584).

The aScopeTM Duodeno is indicated for use with the aBoxTM Duodeno Video System, endoscopic accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

 

954

Share this:

  • Twitter
  • Facebook
  • LinkedIn
  • Pinterest
  • WhatsApp
  • Reddit

Related

Hours & Info

11300 West Olympic Blvd, Suite 600
Los Angeles, CA 90064
1-310-437-0544
[email protected]
Monday - Friday
8am to 5pm Pacific Time

Find Us Around the Web!

  • Facebook
  • Twitter
  • YouTube

Important Links

SAGES 2024 Meeting Information

Healthy Sooner: Patient Information

SAGES Guidelines, Statements, & Standards of Practice

SAGES Manuals

 

  • taTME Study Info
  • Foundation
  • SAGES.TV
  • MyCME
  • Educational Activities

Copyright © 2023 Society of American Gastrointestinal and Endoscopic Surgeons