Class 2 Device Recall Olympus Endoscope Reprocessor OERElite

• Date Initiated by Firm: May 26, 2023
• Date Posted: August 04, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2344-2023
• Recall Event ID: 92633
• 510(K)Number: K201920
• Product Classification: Accessories, cleaning, for endoscope - Product Code FEB
• Product: Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
• Code Information: UDI-DI: 04953170404047 Serial Numbers: 2201375 and the last 4 digits less than 1375
• 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: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
• FDA Determined Cause: Labeling Change Control
• Action: Olympus issued two Urgent: Medical Device Corrective Action letters: (1) VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V (LF-V) TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P (LF-P) (2)ENDOSCOPE REPROCESSOR Affected Models: OER-ProTM, OER-MiniTM and OER-EliteTM. Letters states reason for recall, health risk and action to take: Our records indicate that your facility has purchased one or more LF-V and LF-P scopes. (1)Olympus requests you to take the following actions: 1. Ensure all personnel are completely knowledgeable and thoroughly trained on the changes to the reprocessing instructions described in this letter. 2. If you are using OER for high level disinfection of your LF-V and LF-P, please transition to another compatible method of reprocessing as soon as possible. 3. Locate and replace any on-hand copies of the LF-V and LF-P Instructions for Use with the updated version. Obtain a copy of the updated IFU by accessing our Olympus Connect website: How to access the Instructions for Use a) Log in to www.OlympusConnect.com b) Select Product Support , then Instruction Manuals c) Navigate to the document entitled LF-V Instruction Manual and LF-P Instruction Manual If you require additional information about the updated Instruction for use, or need assistance with accessing Olympus Connect, please contact our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). The TAC department can assist you in answering questions on the new Instructions Manual and new steps. 4. If a Scope ID tag (MAJ-1545) is used with your LF-V and LF-P, please dispose of your MAJ-1545 since the LF-V and LF-P cannot be used with OERs. 5. Complete the enclosed response form and return to our recall partner, Sedgwick, via Email (Olympus6538@sedgwick.com) or Fax (866-842-0470). For any questions about the acknowledgement form, please call the Sedgwick team at 888-912-7350. (2)Our records indicate that your facility has purchased one or more of the afore mentioned endoscope
• Quantity in Commerce: 1063 units
• Distribution: Nationwide
• 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 = FEB