—#167002

Product

Bronchovideoscope BF-240

FDA product code: EOQ — Bronchoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K023984, K963033
Affected lot / code info: all lot codes

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: The products were distributed US nationwide and Canada.

Timeline

Recall initiated: 2018-08-08
Terminated: 2022-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167002. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.