Olympus Scope Infections: Could You Have a Legal Claim?

Endoscopes can help doctors diagnose and treat a wide range of medical conditions without the need for more invasive procedures. Because many endoscopes are reusable, however, healthcare facilities must carefully clean, disinfect, or sterilize them between patients. When that process fails, a contaminated device can expose patients to harmful bacteria and other microorganisms.

The U.S. Food and Drug Administration (FDA) has investigated infections associated with reusable duodenoscopes and has issued safety communications involving the cleaning and reprocessing of these devices. Olympus, one of the major manufacturers of endoscopic equipment, has faced regulatory actions and recalls involving certain scopes and accessories. For patients who developed a serious infection after an endoscopic procedure, these issues can raise an important question: Do you have a case?

The answer depends on what happened during the procedure, what type of Olympus device healthcare providers used, how they reprocessed it, and whether the infection can be connected to the procedure or device.

What Is an Olympus Endoscope?

An endoscope is a medical device that allows doctors to look inside parts of the body and, in some cases, perform procedures. Olympus manufactures several types of endoscopes used in gastrointestinal, urological, respiratory, and other medical procedures. One type that has received significant attention is the duodenoscope. Doctors can use these devices during procedures such as endoscopic retrograde cholangiopancreatography (ERCP), which allows them to diagnose and treat certain conditions involving the bile ducts and pancreatic ducts.

The design of some duodenoscopes can make cleaning and reprocessing more complicated. The FDA has noted that reusable medical devices can retain blood, tissue, and other biological material when healthcare facilities do not properly complete the required cleaning process. That makes proper reprocessing an important part of patient safety.

How Can an Endoscope Cause an Infection?

Reusable endoscopes require multiple cleaning and disinfection steps before healthcare providers use them on another patient. Those steps can include pre-cleaning, manual cleaning, high-level disinfection, sterilization when appropriate, rinsing, drying, and other procedures required by the device’s instructions. If healthcare workers fail to complete those steps correctly, microorganisms can remain inside or on parts of the device.

The FDA has specifically warned about the risk of infections associated with reprocessed duodenoscopes. In its review of these devices, the agency found higher-than-expected contamination rates after reprocessing and emphasized the importance of following manufacturers’ cleaning and maintenance instructions.

This does not mean that every patient who develops an infection after an endoscopic procedure contracted it from the scope. Doctors and patients must consider many possible sources of infection. However, when an infection develops after a procedure, evidence about the device and the facility’s reprocessing practices may become important.

What Infections Have Been Associated With Olympus Scopes?

The FDA and other health authorities have investigated infections involving bacteria such as Pseudomonas aeruginosa and Escherichia coli in connection with contaminated duodenoscopes. For example, the U.S. Department of Justice reported that Olympus pleaded guilty in 2018 after failing to file required adverse-event reports involving infections connected to its TJF-Q180V duodenoscope. The reported infections included cases involving Pseudomonas aeruginosa and E. coli.

More recent FDA records also show recalls involving Olympus duodenoscopes because of reports of patient infections. In one 2023 recall involving the Olympus TJF-Q190V, the company cited recent reports of infections and positive cultures and reminded healthcare facilities to closely follow reprocessing instructions. These regulatory records do not mean that every infection involving an Olympus scope resulted from a defective device. They do, however, show why doctors and patients have taken endoscope contamination seriously.

What Could Make an Olympus Endoscope Infection Case?

Several factors may affect whether a patient has a potential legal claim. One important issue involves causation. A patient generally needs evidence connecting the infection to the medical procedure, device, or actions of a healthcare provider or facility. Simply developing an infection after an endoscopy does not automatically establish that a contaminated scope caused it. The patient’s medical history may also matter. Doctors may need to determine whether another source could explain the infection.

The type of organism can provide additional information. If a patient’s infection involves bacteria that investigators also identify in a contaminated medical device or in other patients treated with the same device, that information could become significant.The timing of the infection can matter as well. Medical records may help establish when the procedure occurred, when symptoms began, and when doctors diagnosed the infection.

Could Improper Reprocessing Support a Claim?

Potentially. Healthcare facilities that reuse endoscopes must follow applicable cleaning and reprocessing requirements. The FDA emphasizes that proper reprocessing plays a critical role in preventing patients from being exposed to contaminated reusable devices. If a facility failed to follow the manufacturer’s instructions or otherwise failed to properly reprocess an endoscope, that conduct could become relevant to a patient’s claim.

The FDA has documented concerns involving Olympus reprocessing systems as well. For example, the agency has issued recalls and corrective actions involving Olympus endoscope reprocessors and changes to compatibility or reprocessing instructions. A potential case therefore may involve more than the scope itself. Investigators may need to examine the healthcare facility’s procedures, training, equipment, maintenance records, and reprocessing documentation.

Could the Endoscope Itself Be Defective?

In some circumstances, a patient may also have questions about the design or safety of the medical device itself. An endoscope can function as intended while still creating challenges during cleaning and reprocessing. A design feature that makes it difficult to adequately clean certain areas could become relevant when investigating repeated contamination or infections.

The FDA has taken regulatory action involving Olympus devices over the years. In 2023, for example, the agency issued warning letters to Olympus concerning medical device reporting and quality-system requirements for endoscopes and related equipment. The FDA stated that those requirements help ensure devices are designed, validated, manufactured, and used safely. However, the existence of an FDA warning, recall, or regulatory action does not automatically prove that a particular patient’s injury resulted from an Olympus device. A case still requires an examination of the individual circumstances.

What Evidence Could Support an Olympus Scope Claim?

Medical records may provide some of the most important evidence. Patients should preserve records from the procedure, including information about the type of endoscope used whenever that information appears in the medical chart. Records may also show the date of the procedure, the healthcare facility, the treating physicians, and any complications that occurred.

If an infection developed afterward, records of symptoms, laboratory testing, hospitalization, antibiotics, and other treatment can help establish what happened.

Other evidence may include:

• Medical records and procedure reports
• Laboratory and culture results
• Information about the specific Olympus device
• Device serial or identification numbers
• Hospital infection-control records
• Reprocessing and maintenance records
• FDA recall or safety information
• Records of similar infections at the facility
• Documentation of additional medical treatment

Patients should not assume they need to collect every piece of evidence themselves. An attorney investigating a potential claim may be able to request records and identify additional information that could help establish what happened.

What If You Developed an Infection After an ERCP?

Patients who develop an infection after an ERCP or another endoscopic procedure should seek medical attention promptly. Some infections can become serious and may require hospitalization, intravenous antibiotics, additional procedures, or other treatment. Patients should follow their healthcare provider’s instructions and report concerning symptoms as soon as possible.

If the infection appears unusual or severe, patients may also want to preserve information about the procedure. Knowing the date and location of the procedure, the type of scope used, and when symptoms first appeared can help an attorney investigate the circumstances.

Do You Have an Olympus Endoscope Injury Case?

If you developed a serious infection after an endoscopic procedure, several questions may help determine whether you have a potential claim. What type of procedure did you undergo? What type of Olympus device did the medical facility use? When did your symptoms begin? What type of infection did doctors diagnose? Did other patients at the facility develop similar infections? Did the facility follow the appropriate reprocessing procedures?

These questions can help distinguish an ordinary medical complication from an injury that may involve a defective medical device, improper reprocessing, medical negligence, or another legal issue. An investigation may also uncover FDA recalls, facility records, or other information that the patient did not know existed.

Alonso Krangle Fight for Victims of Olympus Endoscope Injuries

An infection following an endoscopic procedure does not automatically mean that a defective Olympus device or improper reprocessing caused the illness. At the same time, patients should not dismiss a serious infection without understanding what happened. FDA records show a history of regulatory attention involving reusable duodenoscopes, Olympus devices, and endoscope reprocessing. If you suffered a serious infection after an endoscopic procedure, reviewing your medical records and the circumstances surrounding the procedure may help determine whether you have a potential legal claim.

Alonso Krangle helps injury victims throughout Long Island, Nassau County, Suffolk County, Queens, and New York pursue compensation in complex product liability and medical injury cases. If you or a loved one experienced serious complications or infections following an endoscopy procedure, contact Alonso Krangle LLP for a free consultation and confidential case evaluation. Call us at 800-403-6191 or contact us online for a free consultation and confidential case evaluation.