—#210637

Product

Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product Description: The Olympus UroPass Ureteral Access Sheath Set consists of a hydrophilic coated outer sheath and an inner tapered dilator intended to establish a conduit for the passage of endoscopes and retrieval devices into the ureter. The hydrophilic coating on the UroPass Ureteral Access Sheath eases passage and placement. Both the outer sheath and inner dilator are radio-opaque for ease of viewing radiographically. Intended for single use only. Component: N/A

FDA product code: KNY — Accessories, Catheter, G-U
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K051593
Affected lot / code info: Model/UDI-DI: 61024BX/00821925035317, 61038BX/00821925035324, 61046BX/00821925035331, 61054BX/00821925035348, 61124BX/00821925035355, 61138BX/00821925035362, 61146BX/00821925035379, 61154BX/00821925035386, 61224BX/00821925035393, 61238BX/00821925035409, 61246BX/00821925035416, 61254BX/00821925035423, 61324BX/00821925035430, 61338BX/00821925035447, 61346BX/00821925035454, 61354BX/00821925035461.

Why it was recalled

Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.

Root cause (FDA determination)

Storage

Action the firm took

****UPDATE Nov 8, 2024*** Olympus mailed a revision letter-URGENT: MEDICAL DEVICE CORRECTION UPDATED INFORMATION to consignees on November 8, 2024. Letter states; To reduce the risk of UV exposure to your device(s), Olympus instructs users to implement the following actions: Minimize the exposure of UroPass Ureteral Access Sheaths to ultraviolet light. Exposure to UV light during storage periods may cause embrittlement of this device, increasing the potential for breakage and patient injury, including retained device fragments, tissue damage, or perforation of the ureter. Updated Information: " As instructed in IFU Section 4.0, inspect the device prior to use. If any damage to the device is noted, DO NOT USE. " Inspect the device upon removal or completion of the procedure. If damage is noted, the patient should be evaluated for a potentially retained foreign body. " Sharp edges of a broken sheath have been reported to have caused ureteral tissue damage or perforation. If device damage is noted, patients should be monitored intraoperatively and in the immediate post-operative period for these types of injuries. Olympus is not requiring the return of your UroPass device(s) as a result of this action. However, if you want to return the UroPass device(s) in your inventory, please contact Customer Service at 1-800-848-9024, option 2 to obtain a Return Material Authorization. Olympus will issue a credit to your facility upon return of your affected product. 4. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, including the new information regarding UV exposure. Olympus is in the process of updating the Instructions for Use with this information. 5. Olympus requests that you acknowledge receipt of this letter. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall b. Enter the recall number "0458 c. Complete the form as instructed. 6. If

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Germany, Hong Kong, Japan, Republic of South Korea, Singapore.

Timeline

Recall initiated: 2024-09-11
Posted by FDA: 2024-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210637. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.