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U.S. Department of Health and Human Services

Class 2 Device Recall Bronchovideoscope BFXT160

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  Class 2 Device Recall Bronchovideoscope BFXT160 see related information
Date Initiated by Firm August 08, 2018
Create Date September 29, 2018
Recall Status1 Open3, Classified
Recall Number Z-3308-2018
Recall Event ID 80925
510(K)Number K023984  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product Bronchovideoscope BF-XT160
Code Information all lot codes
Recalling Firm/
Manufacturer
Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information Contact Laura Storms
484-896-5688
Manufacturer Reason
for Recall
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
FDA Determined
Cause 2
Other
Action Urgent Medical Device Safety Notice letters dated 8/8/18 were distributed to customers. The letters instructed customers to perform the following: Our records indicate that your facility has purchased one or more of the above-referenced endoscopes. OLYMPUS requires that you take the following actions: Inspect your inventory for the referenced Olympus models. Please keep this customer letter in your inventory and conduct the following action prior to every use. Step 1: Wearing sterile gloves, attempt to rotate or turn the instrument channel port in counter-clock direction as shown in picture 01. If the instrument channel port is able to be rotated or turned, do not use the endoscope and return it to Olympus for repair. If the instrument channel port does not rotate or turn, go to step 2. Step 2: Visually inspect the rubber part around the instrument channel port of the referenced endoscope. If the rubber part is in a normal condition as shown in picture 02, the endoscope can be used in a patient procedure. If the rubber part is lifted from the molding parts as shown in picture 03, do not use the endoscope and return it to Olympus for repair. If you have any questions about how to conduct this important inspection or you are not sure of the results of your inspection, you should contact the Olympus Technical Assistance Center (TAC), prior to using the device again. The phone number for TAC is 1-800-848-9024 option 1. To request service for your endoscope, contact Olympus at 1-800-848-9024, option 3. If you may have further distributed this product, please identify your customers and inform them at once of this action. Please complete and return the enclosed Reply Form to Olympus at facsimile (484) 896-7128.
Quantity in Commerce 861
Distribution The products were distributed US nationwide and Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = EOQ and Original Applicant = THE OLYMPUS OPTICAL CO.
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