The FDA ran swab surveillance studies on duodenoscopes in active use at hospitals across the United States. The results were striking: even when hospitals followed the manufacturer’s cleaning instructions correctly, roughly 1 in 20 scopes still tested positive for contamination. Some of those scopes harbored drug-resistant bacteria — the kind that can be extremely difficult or impossible to treat with standard antibiotics.
This is the FDA’s own data, not an estimate from outside critics. It documented a real-world failure rate built into how these devices are designed.
If your information appears to qualify you for help, a lawyer or someone from their team will reach out to you. If you don't hear back within seven days, please speak with another law firm — every legal matter has a filing deadline, and waiting too long can cost you the right to recover.
Why Cleaning Doesn’t Always Work
Duodenoscopes — the type of scope used in procedures like ERCP, which examines the bile duct — have a small hinged channel near the tip called the elevator mechanism. It’s used during the procedure to steer instruments. The problem is that this channel is narrow and recessed in a way that makes it very hard to clean.
Unlike most surgical instruments, duodenoscopes can’t be heat-sterilized (autoclaved) because the heat would damage the optics inside. So hospitals use liquid chemical disinfection instead. But that liquid often can’t fully reach the bacteria hiding in the elevator channel — even when every step of the cleaning protocol is followed.
The bacteria that survive can then be transferred to the next patient who has a procedure with that same scope.
What Kinds of Bacteria Were Found
The contamination wasn’t harmless. The FDA’s surveillance found drug-resistant organisms including:
- CRE (carbapenem-resistant Enterobacteriaceae) — considered an “urgent threat” by the CDC. Infections can be nearly impossible to treat.
- Pseudomonas aeruginosa — a bacteria that can cause serious infections in the lungs, blood, and surgical sites.
- Other multi-drug resistant organisms (MDROs) that don’t respond to standard antibiotics.
When a patient picks up one of these bacteria from a contaminated scope, they may not know where it came from. Symptoms often appear days after the procedure, and doctors may initially look for other causes.
If your information appears to qualify you for help, a lawyer or someone from their team will reach out to you. If you don't hear back within seven days, please speak with another law firm — every legal matter has a filing deadline, and waiting too long can cost you the right to recover.
What Has the FDA Done About It
The FDA has issued multiple rounds of guidance since the contamination problem became widely known. Hospitals have been required to add extra cleaning steps, including inspecting the elevator channel with a 10x magnifying tool after every use, using forced-air drying to reduce moisture, and in some cases culturing scopes between uses to check for bacteria.
The FDA eventually went further, recommending that hospitals switch to duodenoscopes with disposable tips — which eliminate the cleaning problem entirely by replacing the high-risk part after every procedure.
As of 2026, that switch has not happened everywhere. Many hospitals are still using the original reusable design.
Signs Something May Have Gone Wrong After Your Procedure
If you had an endoscopic procedure and later developed any of the following, it may be worth looking into:
- Fever or chills in the days after an ERCP, colonoscopy, bronchoscopy, or other scope procedure
- Being diagnosed with an antibiotic-resistant infection — especially CRE, MRSA, or Pseudomonas
- Sepsis (a serious whole-body infection response) after a scope procedure
- An unexpected hospital stay or readmission following a routine scope exam
Who May Have a Case
- You had an endoscopic procedure at a U.S. hospital or surgery center
- You developed a serious infection in the days or weeks that followed
- The infection involved an antibiotic-resistant bacteria
- The infection required hospitalization, extended treatment, or caused lasting harm
- A family member died from an infection after a scope procedure
Every state sets a time limit on how long you have to pursue a case after being injured. If you developed an infection following a scope procedure — even years ago — it may be worth checking whether you still have time to file. It’s free to check.
If your information appears to qualify you for help, a lawyer or someone from their team will reach out to you. If you don't hear back within seven days, please speak with another law firm — every legal matter has a filing deadline, and waiting too long can cost you the right to recover.
Sources
- U.S. Food & Drug Administration. “Duodenoscope Reprocessing: Surveillance and Continuing Concerns.” 2019. Reports contamination rate of 3–5% in compliant-cleaning surveillance study. fda.gov
- U.S. Food & Drug Administration. Duodenoscope reprocessing guidance and safety communications, 2015–2023, including 10x magnification and forced-air drying requirements. fda.gov
- U.S. Senate Committee on Health, Education, Labor, and Pensions. “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.” 2016.
- Drugwatch. “Olympus Scope Lawsuit 2026: Infection, Sepsis & Injury Claims.” drugwatch.com
- Nigh Goldenberg Raso & Vaughn. “Olympus Endoscope Recalls.” nighgoldenberg.com