Class 2 Device Recall Olympus Cystoscope Outer Sheath

• Date Initiated by Firm: September 13, 2024
• Date Posted: November 08, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0351-2025
• Recall Event ID: 95584
• 510(K)Number: K790071
• Product Classification: Endoscope, ac-powered and accessories - Product Code GCP
• Product: Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
• Code Information: Model: WA2280A, UDI: 04042761051729, Lot#: All lots.
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: Cynthia Ow; 647-9993203
• Manufacturer Reason for Recall: Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.
• FDA Determined Cause: Under Investigation by firm
• Action: On October 11, 2024 URGENT: MEDICAL DEVICE CORRECTION letters were sent to consignees. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Examine your inventory and identify the above-listed device. 3. You should not use the Cystoscope Outer sheath, 22.5 French with a GreenLight Laser for BPH therapy until further notice from Olympus. Add a copy of this letter to any on-hand copies of the Instructions for Use. 4. Olympus requests that you acknowledge receipt of this letter. Acknowledge receipt of this letter through the Olympus web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number "0460 c. Complete the form as instructed. 5. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including the device breaking off into the patient, or any associated injuries to the Technical Assistance Center (TAC) at 1- 800-848-9024 (option 1), and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 from Monday through Friday, 9 am to 5 pm EDT, or by e-mail at Cynthia.Ow@olympus.com.
• Quantity in Commerce: 738 units
• Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
• 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 = GCP