Olympus America, the country’s largest manufacturer of duodenoscopes used to treat pancreas and bile duct conditions, announced it is recalling its TJF-Q180V model scope so that it can be modified to reduce the risk of spreading deadly bacterial infections.
The recall was announced the same day the Food and Drug Administration (FDA) issued an updat to a March 2015 Safety Communication providing new instructions for the cleaning and disinfecting of duodenoscopes, which have been blamed for infecting patients with drug-resistant superbugs at more than a dozen hospitals across the country. The update included new instructions for cleaning Olympus’ TJF-Q180V duodenoscope.
Olympus was selling the TJF-Q180V scope even though the device’s approval was pending with the FDA. The agency ultimately approved the specialized endoscope but with design modifications to the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel.
The recall and the FDA’s updated Safety Communication come in the wake of a Senate committee report accusing Olympus of knowing two years ago that its duodenoscopes could harbor bacteria in small crevasses of the surgical tool even after it has been cleaned and disinfected according to manufacturers recommendations, but failed to notify hospitals, physicians or patients of this risk. Nor did the company alert the FDA, as required. The Senate report also cited hospitals for being slow to report infections in patients.
Olympus said it would modify the recalled duodenoscopes with the design modifications recommended by the FDA. Olympus also said it would conduct annual inspections of the recalled duodenoscopes to look for any wear and tear on the elevator channel sealing mechanism, or debris on the scopes’ tip, “which would require replacement of potentially contaminated parts,” the FDA said.