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Medical Device Recalls Olympus America Issues Voluntary Recall of Suspect Video Bronchoscopes

On November 30, 2001, Olympus America, Inc., of Melville, New York initiated a voluntary recall of their bronchoscopes after a medical facility reported that bacteria growing in video bronchoscopes may have been responsible for a patient infection requiring medical treatment. A bronchoscope is a flexible tube with a small light and camera used to evaluate the airway and lungs to diagnose or rule out respiratory problems such as pneumonia and lung cancer.

Olympus issued a recall notification letter to hospitals and medical facilities about the suspect bronchoscopes on November 30, 2001, requesting they be returned to Olympus for modification.

The biopsy port on the video bronchoscope is not intended to be removed from the bronchoscope. However, the medical facility, which reported one illness among patients treated with the bronchoscopes, discovered that the biopsy ports on the bronchoscopes became loose, and could be removed by twisting. Olympus America is repairing the bronchoscopes by applying adhesive to the biopsy port, and is replacing the plastic biopsy port with a port made from stainless steel.

On February 27, 2002, Olympus issued a second recall notification letter to facilities that did not respond to their first letter.

The following are the Olympus Bronchoscope Models that have been recalled:

BF-40, BF-P40, BF-IT40, BF-3C40, BF-XP40, BF-XT40, BF-240, BF-P240, BF-IT240, BF-6C240, BF-160, BF-P160, BF-IT160, BF-3C160, BF-XT160.

The bronchoscopes were distributed nationwide and to Canada, Mexico, Dominican Republic, Argentina, Brazil, Panama, Chile, Peru, Ecuador, Columbia, Venezuela, Paraguay, Uruguay, Costa Rica, and El Salvador between June 5, 1997 and December 10, 2001.

FDA continues to work with Olympus to get this problem resolved.

If you recently had a lung or airway examination with a bronchoscope, and are experiencing respiratory problems, FDA recommends that you contact your physician. In addition, you should report your problem to FDA's MedWatch Reporting Program by telephone, 1-800-332-1088 or on line at http://www.fda.gov/medwatch.

For additional information the recall contact at Olympus is:

Laura Storms-Tyler,
Director, Regulatory Affairs and Quality Assurance
Olympus America Inc.,
Two Corporate Center Drive,
Melville, NY 11747-3157
(631) 844-5688

To contact the Consumer Staff in FDA's Center for Devices and Radiological Health call 1-888-463-6332. When prompted, press 2, press 1, press 3, press 1, and press 5 to speak to a Consumer Affairs Specialist (from 8:00 AM to 4:30 PM EST). To request information after business hours, press 4 and leave a message.

Updated May 8, 2002

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