Endoscope Lawsuit Filed Against Fujifilm After Equipment Failure Leads to Injuries

Complaint comes as the industry faces a growing number of lawsuits over endoscope infections caused by design defects with certain reusable products, which may be impossible to clean between patients.

A Texas woman has filed a product liability lawsuit against Fujifilm, indicating she suffered hearing damage when part of one of its endoscopes exploded during a demonstration.

The complaint (PDF) was brought by Elizabeth Morell in the Texas state court for Dallas County in June. Defendants named in the lawsuit include Fujifilm Healthcare Americans Corp. and Jeremy Roper, who removed the case to the federal court system late last month.

Morell claims that she was wearing hearing aids which amplified the sound when Fujifilm employee Roper connected a sterile water bottle to a carbon-dioxide insufflator and clamped the tubing, allegedly preventing excess pressure from venting and causing the bottle to explode.

Endoscope Infection Risks

The lawsuit comes as the medical device industry faces renewed scrutiny over the safety of its endoscopes, which are thin flexible tube-like camera devices inserted into orifices to help doctors see inside of patients. They are frequently used for colonoscopies and similar procedures like ERCP, upper endoscopy and bronchoscopy.

Because the devices are frequently used on multiple patients, healthcare professionals must carefully and thoroughly sterilize the devices between each procedure, which is also frequently referred to as “reprocessing.” If not cleaned properly, bacteria, biofilm, tissue and other debris may remain trapped inside the scopes, especially in narrow channels or damaged areas that are difficult to inspect. This could potentially expose patients to infections or blood-borne diseases.

As a result, a growing number of scope infection lawsuits have been filed in recent months, each raising allegations that various companies’ endoscope devices are defectively designed and create an unnecessary infection hazard for patients.

Fujifilm Endoscope Equipment Failure Allegations

While Morell’s lawsuit is not about an infection, she claims negligence involving the use of Fujifilm endoscope equipment resulted in serious injuries.

According to Morrell, she was an employee at Texas Health Presbyterian Hospital-Plano in March when Roper came to demonstrate new Fujifilm endoscope equipment and how to use it. As part of the process, he connected a sterile water bottle to a carbon-dioxide insufflator, which helps to keep the endoscope camera’s lens clean and helps with irrigation while in use.

“During the demonstration, Roper clamped the sterile water bottle tubing, preventing the bottle from venting excess pressure. The trapped pressurized gas caused the bottle to burst.”

– Elizabeth Morell v. Fujifilm Healthcare Americans Corp. et al.

At the time, Morell was wearing hearing aids that were amplifying sounds, including the explosion. The lawsuit alleges she suffered severe hearing damage as a result. It also states that while Roper was clearly an employee of Fujifilm, she is unaware of his position in the company and has been unable to locate him.

Fujifilm has denied that it or Roper caused Morell’s injuries and offered a different account of how the explosion occurred. In a July 10 court filing, the company claims a Texas Health Resources employee disregarded Roper’s instructions to turn off the carbon dioxide flow and instead turned the valve on, causing the bottle to burst.

The company maintains the employee’s actions, as well as alleged negligence by Texas Health Resources, caused or contributed to the incident, and has asked the court to designate the hospital system as a responsible third party.

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