Class 2 Device Recall Olympus

• Date Initiated by Firm: March 08, 2022
• Create Date: May 06, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1049-2022
• Recall Event ID: 89942
• 510(K)Number: K061313
• Product Classification: Bronchoscope (flexible or rigid) - Product Code EOQ
• Product: BF-1TQ180: EVIS EXERA II Bronchovideoscope
• Code Information: All serial numbers. UDI: 04953170339349
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: SAME; 484-896-5000
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Other
• Action: 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
• Quantity in Commerce: 242 units
• Distribution: US Nationwide distribution.
• 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 = OLYMPUS MEDICAL SYSTEMS CORPORATION