URGENT - RECALL

November 30, 2001

RE: Olympus Bronchoscope
Models: BF-40, BF-P40, BF-1T40, BF-3C40, BF-XP40, BF-XT40, BF-240, BF-P240, BF-1T240, BF-6C240, BF-160, BF-P160, BF-1T160, BF-3C160, BF-XT160

Dear Health Care Practitioner:

Olympus America Inc. is initiating a recall for the Olympus Bronchoscope models described above to address a potential looseness in the biopsy channel port housing. We are initiating this action after receiving a customer complaint regarding a loosened bronchoscope biopsy port and microbial contamination of the port. An additional contributing factor in this instance was the failure by the user to maintain the Automated Endoscope Reprocessor (AER) to the manufacturer's recommended instructions.

As a result, Olympus America Inc. would like you to take the following actions:

  1. Please check that you are following all labeled instructions for reprocessing, either manual or automated, for your bronchoscope. If you are utilizing an AER, ensure that all scheduled maintenance is being performed.

  2. Utilizing the attached procedure, please inspect your inventory of Olympus bronchoscope models (referenced above) for looseness in the biopsy channel port. If you detect any looseness in the biopsy channel port, please discontinue use of this bronchoscope and return the endoscope to Olympus' repair facility as noted below.

    If no looseness is detected in the biopsy channel port, you may continue to utilize the bronchoscope, however, Olympus would like you to return the bronchoscope at your convenience so that we can upgrade the biopsy port housing.

    All bronchoscopes should be returned to:

    Olympus National Service Center
    ATTN: Bronchoscope Modification
    2400 Ringwood Avenue
    San Jose CA 95131-1700

    Return shipments to Olympus should be sent via Federal Express (FedEx 2Day service). Please indicate in the "Bill to" section of the FedEx form to bill recipient (Olympus). It is estimated that your bronchoscope will be returned to you within 48-hours after receipt at Olympus.

    In order to return your bronchoscope in the shortest possible timeframe, Olympus will be servicing only the biopsy channel port and will not inspect the bronchoscope for other repair/service issues. Bronchoscopes serviced prior to December 10, 2001 have not been modified for the biopsy port.

Enclosed is a questionnaire we would like you to complete indicating you have received, read and understood this information, as well as provide a contact name and phone number for your facility. Please send this information to Mary Anne Pizzinga at facsimile number (631) 844-5554 or (631) 844-5416.

Olympus America regrets the necessity of this action, and fully appreciates your cooperation in addressing this situation. Please do not hesitate to contact me directly at (631) 844-5688 for any additional information on this matter.

Sincerely,

Laura Storms-Tyler
Director, Regulatory Affairs & Quality Assurance


 

Olympus Bronchoscope Recall


Affected Models: BF-40, BF-P40, BF-1T40, BF-3C40, BF-XP40, BF-XT40, BF-240, BF-P240, BF-1T240, BF-6C240, BF-160, BF-P160, BF-1T160, BF-3C160, BF-XT160

I have received the Recall information on the Olympus Bronchoscope models referenced above and understand that I need to return my unit for replacement of the biopsy port.

Model and Serial number of affected bronchoscope(s):

___________________________________   ___________________________________
___________________________________   ___________________________________
___________________________________   ___________________________________
___________________________________   ___________________________________
___________________________________   ___________________________________
___________________________________   ___________________________________

Name: ______________________________________________

Institution: ___________________________________________

Address: ____________________________________________

City: __________________________ State: _______ Postal code: _______________

Phone number: _______________________________________


Fax completed questionnaire to Mary Anne Pizzinga at (631) 844-5554 or (631) 844-5416


Olympus America Inc.
Two Corporate Center Drive
Melville, NY 11042-1179

 

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