Class 2 Device Recall Olympus

• Date Initiated by Firm: November 02, 2021
• Date Posted: December 10, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0379-2022
• Recall Event ID: 88981
• 510(K)Number: K143153
• Product Classification: Duodenoscope and accessories, flexible/rigid - Product Code FDT
• Product: EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
• Code Information: All serial numbers. UDI: 04953170339967
• 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: Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.
• FDA Determined Cause: Under Investigation by firm
• Action: Olympus issued Urgent Medical Device Corrective Action on 11/02/21. Letter states reason for correction, health risk and action to take: 1. Consider transitioning from TJF-Q180V to a next generation duodenoscope through the Olympus incentive program. 2. Increase preventative maintenance frequency from annual to 6 months. 3. Evaluate existing duodenoscopes: https://medical.olympusamerica.com/TJFQ180VChecklist 4. The Technical Assistance Center (TAC) can assist you in answering questions on the TJF-Q180V inspection steps. 1-800-848-9024, option 1. 5. Use in-service training, the Olympus Video Guide, e-learning and on demand library to support staff training. ***UPDATE: Olympus issued an Urgent Medical Device Corrective Action UPDATED INFORMATION on 1/17/22. This is an update to the 11/2/21 previously provided supplemental material for inspection. In alignment with FDA Safety Communication dated August 29, 2019, and to further expedite transition to newer-generation duodenoscopes, Olympus America will soon begin offering customers with the older generation TJF-Q180V2 scopes a direct, no-cost 1 for 1 replacement with the state-of-the-art TJF-Q190V. Your Olympus sales representative will contact you regarding this program in the near future. In the interim, please continue to utilize the TJF-Q180V Inspection Checklist that Olympus recently sent. Olympus America will also be increasing the frequency of proactive inspection from once every twelve (12) months to once every six (6) months. To help minimize any potential patient impact regarding access to critical, life-saving ERCP procedures, loaners are available to mitigate disruption to healthcare facilities who need to return their duodenoscope(s) to Olympus for repair. For any questions or concerns, please do not hesitate to contact me directly at Cynthia.Ow@Olympus.com.
• Quantity in Commerce: 14,447 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 = FDT