—#210677

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

FDA product code: GCP — Endoscope, Ac-Powered And Accessories
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K790071
Affected lot / code info: Model: WA2280A, UDI: 04042761051729, Lot#: All lots.

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-09-13
Posted by FDA: 2024-11-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210677. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.