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 bacteria growing in video bronchoscopes, which possibly caused two illnesses. 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.

Olympus determined the original biopsy channel port was made of plastic, and fitted with a cap that was not intended to be removable. However, the medical facility, which reported two illnesses among patients treated with the bronchoscopes, discovered the caps on the two bronchoscopes used became loose, and could be removed by twisting. Olympus is replacing the bronchoscopes' biopsy channel port with a port made from stainless steel, which will not bend or distort during use or reprocessing. In addition, Olympus will use more adhesive to hold the cap in place and prevent the cap from loosening.

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 on this recall you can access the firm's web site at: http://www.olympusamerica.com/innards/h_endoscopy.asp?s=11&p=15
The recall contact 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 1, press 2, press 2, press 3, and press 1. To speak to a Consumer Affairs Specialist (from 8:00 AM to 4:30 PM EST), press 5. To request information after business hours, press 4 and leave a message.

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Updated 3/20/02