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.
The BF-H190 routine bronchoscope provides high definition images of unprecedented quality in white light and NBI mode.
This new flagship of Olympus diagnostic bronchoscopes features:
- increased upward angulation
- stunning insertion tube rotation function for precise targeting of EndoTherapy instruments
- 2.0 mm working channel
- one-touch connector to the video system
|OLYMPUS AMERICA, INC. OLYMPUS BRONCHOSCOPE (FLEXIBLE OR RIGID)||Back to Search Results|
In July 1998, the facility began processing bronchoscopes and other endoscopes using a STERIS System 1 processor. The facility used Pentax (Pentax, Orangeburg, New York) and Olympus bronchoscopes but did not document the specific bronchoscope used on each patient. Neither the Pentax nor the Olympus bronchoscopes were connected to the STERIS System 1 in accordance with the STERIS manufacturer's recommendations. The person responsible for cleaning and disinfecting the endoscopes had received training at the STERIS Corporation; however, the specific scopes used at the facility were not demonstrated during the training.
Cecil Young, a Memphis, Tenn., property appraiser, died in June 2001 after being treated with an Olympus bronchoscope that would be recalled later that year.