When Routine Procedures Carry Unexpected Risks
Endoscopic procedures, such as colonoscopies, bronchoscopies, and ERCPs (endoscopic retrograde cholangiopancreatography), are used to diagnose a variety of conditions affecting the upper and lower gastrointestinal tract, as well as the biliary tract. However, major recalls show that a design defect has led to a series of major infections. The recalls explain that even when the scopes used in these procedures are cleaned or disinfected according to the manufacturer’s instructions, they can still transmit dangerous bacteria from one patient to another.
Scope-related infections are often linked to systemic failures, including defective device design and lapses in infection control practices. These failures can result in serious patient harm, including severe infections, sepsis, and in some cases, death.
How Much Is Your Case Worth?
How Scope Infections Occur
Flexible endoscopes are complex medical devices with narrow channels that can trap biological material. If strict cleaning and high-level disinfection procedures are not followed or if the equipment is inherently difficult to sterilize, harmful pathogens can survive and spread. In many cases, it is alleged that bacterial infections can occur even when the device is reused in accordance with manufacturer recommendations.
Common Endoscopic Procedures:
- Colonoscopy
- Upper endoscopy (EGD)
- ERCP
- Bronchoscopy
- Hysteroscopy
- Sinus endoscopy
Duodenoscope defects
- Contamination-retention / reprocessing defect: the device can remain contaminated even after recommended cleaning because the design is hard to fully disinfect. The FDA (Food and Drug Administration) has specifically identified concerns with device design, reprocessing methods, and cleaning/disinfection instructions.
- Elevator mechanism design defect: the elevator and surrounding recesses are repeatedly singled out because they are difficult to access and clean, creating a known infection-transmission risk. The FDA and ASGE (American Society for Gastrointestinal Endoscopy) both highlight this area as a special problem point.
- Fluid invasion / sealing defect: failures in seals, channels, caps, or adhesive can allow fluid to get into areas that cannot be properly cleaned or otherwise prevent effective reprocessing. FDA specifically noted deterioration of adhesive in one recalled Olympus duodenoscope as a contamination risk.
- Disposable-component / end-cap failure: defects involving distal caps, disposable elevator pieces, or related redesign features can undermine the very safety improvements intended to reduce contamination risk. FDA and ASGE both discuss these newer designs as responses to persistent reusable-scope problems.
- Internal sheath/channel damage: tears, scratches, or microdamage inside the scope can create crevices for bacteria or interfere with cleaning. FDA adverse-event reporting includes a case where borescope (Internal camera) inspection found a small tear within the inner sheath of an ERCP duodenoscope in the context of suspected linked infections.
Severe Infections Can Cause Lasting Harm
Common conditions linked to contaminated scopes include:
- Antibiotic-resistant infection (e.g., CRE, E. coli)
- Sepsis or bacteremia
- Internal organ failure
- Pneumonia or severe pulmonary infection
- Severe bacterial infections
These infections may require prolonged hospitalization, intensive care, multiple surgeries, or can result in permanent disability.
When Infections Become Fatal
In the most serious cases, scope-transmitted infections lead to wrongful death, particularly when antibiotic-resistant bacteria are involved or diagnosis is delayed. Families may be left with unanswered questions about how a seemingly routine procedure turned deadly.
Who May Be Responsible
Scope infection cases often involve multiple liable parties due to the complex chain of responsibility in healthcare settings.
- Medical device manufacturers
- Hospitals and surgical centers
- Physicians and proceduralists
- Nurses and sterilization staff
- Third-party equipment cleaning or maintenance providers
Identifying liability requires a deep investigation into the possibility of both human error and/or systemic breakdowns.
Building a Case for Accountability
These cases are highly technical and require a detailed understanding of both medical procedures and infection control standards.
McEldrew Purtell’s approach includes:
- Reviewing sterilization logs, maintenance records, and infection reports
- Analyzing hospital compliance with CDC (Centers for Disease Control) and manufacturer guidelines
- Consulting infectious disease and medical device experts
- Tracing infection outbreaks to identify patterns or clusters
- Investigating prior warnings, recalls, or known device defects
We work to uncover not just what happened, but why.
Why Contact McEldrew Purtell?
When a preventable infection causes catastrophic harm or loss of life, our firm is prepared to act. We understand the complexity of these cases and the toll they take on patients and families.
Our team is committed to conducting thorough, evidence-driven investigations, holding healthcare systems and manufacturers accountable, and providing clear guidance and support throughout the legal process
If you or a loved one suffered a serious infection following a medical procedure, you deserve answers and a path forward. Contact us today for a free consultation.
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