|March 13, 2002|
|For more than 50 years, Olympus medical devices have been used on millions of patients annually to perform minimally invasive diagnostic and therapeutic procedures. Patient health and safety is and always will be Olympus's highest priority.
Our commitment to the physicians who use our equipment, as well as the patients who undergo endoscopic procedures, is supported by the fact that Olympus America Inc. ( hereinafter referred to as OAI ) elected to initiate an immediate, vigorous investigation and voluntary recall of certain Olympus bronchoscope models based on an incident from a single hospital. ( A "voluntary" recall is an action taken by a manufacturer unilaterally without being required to do so by the FDA. ) In early December 2001, OAI formally informed the FDA that it was initiating this voluntary recall. At the time of the decision to commence the recall, OAI had received a report of Brochoalveolar Lavage ( BAL ) sample contamination and a single patient infection. OAI has worked and will continue to work diligently with the U.S. Food and Drug Administration ( FDA ), the Centers for Disease Control ( CDC ), and hospitals. Olympus remains committed to ensuring that the recall of our bronchoscopes is completed expeditiously.
In Japan, the relevant Japanese health authorities were similarly notified by Olympus Optical Co., Ltd. ( hereinafter referred to as Olympus Optical ) on December 18, and a domestic recall was initiated. Olympus Optical has carried out the recall in Japan in accordance with corresponding domestic guidelines. With regard to Europe and other areas worldwide, similar measures have been implemented in accordance with local guidelines. In addition, instrument channel ports on all bronchoscopes currently being shipped by Olympus Optical have been modified.
There have been recent reports in the media alleging a cause-and-effect relationship between Olympus bronchoscopes and cases at Johns Hopkins Hospital in Baltimore, Maryland ( USA ), in which hospital patients were allegedly infected with Pseudomonas aeruginosa bacteria. ( Pseudomonas aeruginosa is a bacterium widely found in nature, particularly in soil, water, and wastewater. While generally not harmful to healthy individuals, it may cause sepsis and pneumonia in individuals with low levels of resistance. ) Olympus is fully engaged in the process of gathering and evaluating information to determine the cause and effect of these alleged patient infections. At this time, Olympus has not received evidence that these alleged patient infections are attributable to Olympus bronchoscopes subject to the recent recall ( i.e., bronchoscopes that may have contained a loose biopsy port ).
As a company that has a long and successful history in the medical device industry, Olympus has always accorded patient safety and quality-of-life the highest priority. Olympus therefore remains fully committed to the investigation of all issues regarding Olympus medical products, and will continue to cooperate fully with all relevant authorities in regard to the current matter.
*Olympus Optical Co., Ltd. was changed to OLYMPUS CORPORATION as of October 1, 2003.
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