Letter from Olympus

Dear Healthcare Professionals, Patients and Family Members –

This letter provides an update on certain developments regarding our duodenoscopes. These devices, like all the products we manufacture, help millions of people lead safer, healthier, and more fulfilling lives. We seek to create the best possible medical equipment for healthcare providers and ensure the safe and effective use of our products.

Duodenoscopes enable doctors to perform important, and often life-saving, diagnoses and treatments that would otherwise require significant abdominal surgery. More than 600,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed safely in the United States each year; with roughly 500,000 performed using an Olympus device. The reported incidence of infection following an ERCP procedure remains extremely low, with a medical device report incidence rate of well less than 0.1% in the United States.

At the same time, we recognize that the world of medicine is imperfect and complications that affect patients can occur following procedures involving our products. Most recently, duodenoscopes have been linked to certain incidents of infection.

Any report of complications involving a patient’s health is serious and requires appropriate investigation. To address the matter, we have been working with the FDA, health care providers, hospitals, and others to understand the cause or causes of the infections, to implement reprocessing enhancements designed to further reduce the risk of infections to patients and to educate health care professionals about the importance of strictly adhering to our Instructions for Use of Olympus duodenoscopes.

As part of these efforts, we implemented a corrective action in 2016 to replace the forceps elevator mechanism of our TJF-Q180V duodenoscopes. At the same time, we updated our instructions for use, which now include an annual inspection for the TJF-Q180V duodenoscope.

We are also doing much more. During the past year alone, we have provided grants amounting to hundreds of thousands of dollars and in-kind contributions of more than $1.6 million for research into reprocessing and infection control. And since 2015, many more medical professionals have benefitted from the on-site training and education seminars we provide specifically focused on increasing awareness and enhancing the skills required to reprocess our devices properly. Additionally, we developed and continue to develop new print materials and videos for our customers to help guide proper reprocessing.

Finally, our research and development teams are committed to exploring new designs, materials and other variables for our next generation of products. Our priority remains the safety of our patients and the satisfaction of our customers. We will continue to work with customers, medical societies, governments and others to seek to deliver the best and safest products to market.

Thank you for your continued support.