—#201895

Product

Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.

FDA product code: FEB — Accessories, Cleaning, For Endoscope
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K120357
Affected lot / code info: UDI-DI:- 04953170331619 Serial Numbers: 2300314 and the last three digits less than 314

Why it was recalled

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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

Recalling firm

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

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2023-05-26
Posted by FDA: 2023-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201895. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.