How a Medical Device Maker Kept U.S. Hospitals in the Dark about Deadly Infections

The hunt for a deadly superbug that sickened 22 patients at a Dutch hospital began just before noon on a spring day in 2012. Inside a lab in the tiny hamlet of Zoeterwoude, a technician carefully peeled back the tip of a state-of-the art medical scope. Watching him intently was a small group of hospital officials and executives from Olympus Corp., the maker of the device.The Olympus technician found trouble right away. He spotted a brown, grimy film inside parts of the flexible, snake-like scope — parts that were supposed to be sealed. A rubber ring designed to keep bacteria out was cracked and worn. The same bacteria that had sickened the patients were found on the scope.

An investigator hired by Olympus and the hospital concluded that the scope’s design could allow blood and tissue to become trapped, spreading bacteria from one patient to another. In his report, he called on Olympus to conduct a worldwide investigation and recall all its scopes if similar problems turned up. Over the next three years, 21 people died and at least two dozen more became ill from infections related to scopes in Pittsburgh, Seattle and Los Angeles. An unknown number of other patients have been infected. The Food and Drug Administration has identified 10 outbreaks, seven of which involve Olympus scopes.

Even as patients died and others were put at risk, Olympus continued to sell the device and failed to warn U.S. hospitals that the scopes were tied to dangerous infections, according to interviews with dozens of hospital officials, doctors, regulators and former Olympus employees. After each outbreak, Olympus contended that its scopes did not cause the infections and blamed the hospitals for not cleaning them properly. The company treated each case as an isolated incident, not telling the U.S. hospitals that they weren’t alone...