What Are Endoscopes and Why Are They Dangerous?
Endoscopes are thin, flexible tubes equipped with cameras and instruments that allow physicians to examine and treat the interior of the body through natural openings or small incisions, without open surgery. They are used in a wide range of common procedures including colonoscopies, upper endoscopies, bronchoscopies, ERCPs, laparoscopies, ureteroscopies, hysteroscopies, sinus endoscopies, and cystoscopies.
Because endoscopes are reused across multiple patients, they must be thoroughly cleaned and disinfected between procedures. The problem is that some endoscope designs — particularly those with complex internal channels, recessed mechanical components, and narrow lumens — cannot be fully cleaned using currently available reprocessing methods, allowing bacteria from one patient to survive and be transmitted to the next.
The Superbug Outbreak Crisis
Since at least 2012, endoscope-related infections have caused outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) — one of the most dangerous drug-resistant superbugs known to medicine, with a mortality rate of approximately 50% in severe cases — at hospitals nationwide including facilities in California, Washington, Illinois, and Pennsylvania. The U.S. Senate Health, Education, Labor, and Pensions Committee estimated that approximately 250 patients developed CRE infections from contaminated endoscopes at major U.S. hospitals during a single outbreak period.
Endoscope-related infections are not limited to CRE. Patients have also been infected with E. coli, MRSA, ESBL-producing bacteria, Pseudomonas aeruginosa, and other drug-resistant organisms — many of which are difficult or impossible to treat with standard antibiotics and can cause organ failure, prolonged hospitalization, and death.
What the FDA Has Done
In June 2025, the FDA issued import alerts covering 58 models of endoscopic medical devices manufactured by Olympus at its Aizu facility in Japan, citing ongoing Quality System regulation violations and compliance failures [1]. The FDA has also issued warning letters, safety communications, and enforcement actions against other endoscope manufacturers for reprocessing design failures and inadequate disclosure of known contamination risks.
Despite years of warnings and regulatory action, endoscope-related infections continue to occur at hospitals across the country — in part because the fundamental design problems identified in these instruments have not been fully resolved, and in part because hospitals may not always follow the most current reprocessing guidelines.
Who May Be Liable
Depending on the facts of each case, potentially liable parties in an endoscope infection lawsuit may include the manufacturer of the endoscope, the hospital or medical facility where the procedure was performed, and the reprocessing equipment manufacturer. Manufacturers who knew or should have known that their instruments could not be safely cleaned between patients, and who failed to disclose that risk to regulators, hospitals, and patients, face significant legal exposure.
In 2017, a jury ordered one major endoscope manufacturer to pay $6.6 million to a hospital after a superbug outbreak resulted in patient deaths. That same manufacturer was subsequently fined more than $85 million by the U.S. Department of Justice for failing to file required adverse-event safety reports — an admission that came with a federal criminal guilty plea.
Who May Qualify for a Lawsuit
Attorneys are currently reviewing claims from patients who underwent one of the following endoscopic procedures from 2018 to present:
- Laparoscopy
- Colonoscopy
- ERCP (Endoscopic Retrograde Cholangiopancreatography)
- Bronchoscopy
- Upper Endoscopy
- Ureteroscopy
- Hysteroscopy
- Sinus Endoscopy
- Cystoscopy
To qualify, patients must have suffered one or more of the following injuries as a result of the endoscopic procedure:
- Organ or tissue damage or perforation
- Dislodging or breaking of an endoscopic device component
- Hemorrhaging that resulted in a prolonged or unplanned hospital stay, blood transfusion, or other medical intervention causing pain and suffering
- Death from infection or component failure
- Sepsis or bacteremia
- Bacterial infection requiring hospitalization within 90 days of the procedure
- Pneumonia or severe pulmonary infection within 90 days of the procedure
- Tuberculosis within 90 days of the procedure
- HIV diagnosis within 90 days of the procedure
- Diagnosis of a drug-resistant superbug infection (such as CRE or E. coli) within 180 days of the procedure
An endoscope-related infection may appear as quickly as 24 hours after a procedure or as late as 30 or more days afterward. Symptoms that may indicate a post-procedure infection include fever, chills, unusual pain, swelling, rash, or bleeding.
Can I File a Lawsuit?
Patients who underwent a qualifying endoscopic procedure from 2018 to present and suffered any of the injuries listed above may have significant legal options regardless of which manufacturer’s endoscope was used in their procedure. Contact an attorney promptly to have your case evaluated.
References
1. https://www.fda.gov/medical-devices/letters-health-care-providers/import-alerts-certain-olympus-medical-devices-manufactured-japan-letter-health-care-providers