—#192954

Product

BF-3C160: EVIS EXERA Bronchovideoscope

FDA product code: EOQ — Bronchoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K023984
Affected lot / code info: All serial numbers. UDI: 04953170340031

Why it was recalled

Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

Root cause (FDA determination)

Other

Action the firm took

Olympus issued Urgent Medical Device Correction Letters on 3/8/22. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory for the referenced devices and identify any device with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Carefully read the content of this Medical Device Correction Action as well as the attached Addendum . The addendum provides updated information or instructions on the chemicals to be used for reprocessing, the sterilization conditions, rinsing after high-level disinfection, and a recommendation on using sterilization. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the new reprocessing steps. 4. Additional copies of the new Operation Manuals can be obtained by accessing our OlympusConnect site and downloading a copy of the new Manuals. Please visit our OlympusConnect customer website: at https://www.OlympusConnect.com. New users will need to register. Once registered select [Product Support] on the left navigation bar, then select [Instruction Manuals], locate the BF-XT160, BF-XP160F, BF-MP160F and BF-3C160 and select the [Download] option. 5. Access the Olympus portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the reference number 0405 and provide your contact information as indicated in the portal. 6. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. Contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1. The TAC department can assist in answering questions on BF-XT160, BF-XP160F, BF-MP160F and BF-3C160 bronchoscope cleaning and reprocessing. " Olympus America has dedicated field personnel, called Endoscopy Support Specialists, who visit customer sites to assess and observe customer reprocessing methods and to

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2022-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192954. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.