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Earlier in 2016, Olympus Corp. announced a voluntary recall of its endoscopic device, the duodenoscope. The decision came after years of reports linking it with serious, if not fatal infections in patients.

Multiple studies have identified the duodenoscope’s biggest flaw related to these infection risks – a tip design that’s difficult to clean and sterilize thoroughly, even when medical professionals follow proper procedures. The company plans to redesign this aspect, but, in the meantime, Olympus is facing multiple lawsuits from patients who got an infection from a routine procedure.

Background

A type of endoscope, the duodenoscope is a long, flexible tube with a diameter no wider than a pen that features a camera, light and instruments at the end. During a medical procedure, such as checking for gallstones or pancreatic cancer, the device is inserted through the mouth and guided through the stomach to the intestines. For the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure, doctors have used the duodenoscope to some degree on roughly 500,000 patients.

Since 2012, more than 140 patients have reported major infections after going through an ERCP, including cases of Carbapenem-resistant Enterobacteriaceae (CRE), an antibiotic-resistant superbug with a 50-percent fatality rate. Yet, Olympus allegedly knew about the associated risks back then, but made no attempt to correct the issue, claiming medical professionals weren’t cleaning it sufficiently.

In perhaps one of the most serious cases, February 2015 saw at least 179 patients exposed to CRE after undergoing duodenoscope procedures at a Los Angeles hospital. Before this occurrence, Seattle’s Virginia Mason Medical Center experienced a similar outbreak of CRE from 2012 to 2014.

Following the incident in Los Angeles, the FDA published a safety communication letter in early 2015, warning of the difficulty in sterilizing the duodenoscope’s tip. The document stated that brushes can’t fully clean its microscopic crevices, where residual body fluids and other organic debris may become trapped after a procedure. When these particles remain, the risk of patient-to-patient infection grows.

The letter came after the FDA received 75 medical device reports covering 135 patients from January 2013 to December 2014 concerning the duodenoscope. In response, the FDA stated it plans to continue monitoring the scope’s use and relationship between infection and other diseases.

Roughly a year later, Olympus officially announced its recall, which followed a report from a U.S. Senate committee that detailed 25 outbreaks and three deaths directly linked to the scope. “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients” stated multiple infections are associated with the duodenoscope and that Olympus failed to meet regulatory obligations, didn’t get FDA clearance before putting it on the market and didn’t effectively test it in a real-world setting. Along with Olympus, the report also named devices from Pentax and Fujifilm.

Lawsuits

Since the FDA’s safety communication, patients have come forward to file lawsuits against Olympus, including the family members of a patient who died in Los Angeles. These lawsuits accuse Olympus of negligence for selling the device without cleaning instructions and for changing the device in 2014 without updating its documentation for medical professionals.