A duodenoscope is a flexible endoscope used during endoscopic retrograde cholangiopancreatography, or ERCP, a medical procedure involving the bile ducts and pancreatic ducts.
During ERCP, medical professionals guide the scope through the mouth, stomach, and small intestine to reach the opening where these ducts drain, then use contrast dye and X-ray imaging to identify blockages, narrowing, stones, or other problems.
The device also has channels that let physicians pass tools through the scope to remove gallstones, place stents, take samples, or perform other treatment without open surgery.
Unlike simpler medical instruments used for routine upper endoscopy, a duodenoscope has a specialized elevator mechanism near the tip that helps control accessories during the procedure.
That same moving part is one reason duodenoscopes became central to infection concerns, because it creates tight spaces that are harder to fully clean and disinfect between patients.
FDA notes that duodenoscopes are used in more than 500,000 ERCP procedures each year in the United States.
ERCP with a duodenoscope is commonly used to:
- Treat blocked bile ducts: including obstruction caused by gallstones, scarring, or tumors.
- Remove bile duct stones: using small tools passed through the scope.
- Place or replace stents: to keep narrowed ducts open and restore drainage.
- Evaluate pancreatic and biliary disease: including strictures, leaks, and other duct problems.
- Perform minimally invasive treatment: by combining endoscopy with X-ray guidance instead of open surgery in many cases.
Why Duodenoscopes Have Been Linked to Infection Risk
Duodenoscopes have been linked to infection risk because the part of the device that makes ERCP possible also makes the device harder to fully reprocess between patients.
FDA says these scopes have complex designs with reusable hard-to-clean components, and studies of Olympus devices have focused on the elevator area near the tip, where fluids and debris can remain after use.
Standard sterilization and high-level disinfection depend on cleaning agents reaching every exposed surface, but the small recesses, moving parts, and enclosed spaces around the elevator can prevent that from happening consistently in real clinical settings.
Published research on duodenoscope contamination also describes biofilm formation inside channels and other difficult-to-clean areas, which can protect bacteria from detergents and disinfectants and leave ongoing contamination risks for later patients.
That is why patient infections have been reported even when medical providers followed the manufacturer’s instructions for cleaning and other proper procedures, and why FDA has said infections occur despite adherence to manufacturer cleaning protocols.
Many of those infections involved resistant organisms and became severe infections, including sepsis and cases requiring IV antibiotics, which makes them unlike ordinary bacterial infections seen after minor illness.
FDA continues to urge hospitals and medical device manufacturers to move toward partially or fully disposable duodenoscopes, stating that these designs may reduce between-patient contamination by half or more.
Federal scrutiny has also moved beyond cleaning instructions alone, with later Olympus enforcement actions citing quality system regulations alongside the older reprocessing concerns.
