Class 2 Device Recall Olympus CHFCB30S Choledoscope

• Date Initiated by Firm: August 31, 2020
• Create Date: October 16, 2020
• Recall Status: Terminated on December 06, 2022
• Recall Number: Z-0119-2021
• Recall Event ID: 86367
• Product Classification: Choledochoscope and accessories, flexible/rigid - Product Code FBN
• Product: Olympus CHF-CB30S Choledoscope; ; Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).
• Code Information: All lot codes..
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; PO Box 610; Center Valley PA 18034-0610
• For Additional Information Contact: Laura Storms; 484-896-5000
• Manufacturer Reason for Recall: The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of metal parts, as well as breakage and displacement of the rubber on the bending section during surgical procedures.
• FDA Determined Cause: Device Design
• Action: All affected customers were sent a "URGENT: MEDICAL DEVICE REMOVAL ACTION" letter on 08/31/2020 stating the following: Olympus Corporation notified direct customer accounts on 08/31/2020 via recall notification letter. Letter states reason for recall, health risk and action to take. Actions to be taken by customers including the following: 1. Inspect your inventory and identify any CHF-CB30S devices. 2. Cease any further use of any CHF-CB30S device you have, remove it from your inventory and quarantine it until it is shipped back to us. 3. Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization for you to return any CHF-CB30S at no charge. 4. Olympus will reimburse you for each returned CHF-CB30S. Please contact our customer Service representative as indicated in step 3 for the reimbursement amount for your CHF-CB30S choledoschope. 5. Access the Olympus recall portal to indicate that you have received this notification. go to https://olympusamerica.com/recall. Enter the recall number Recall-0365 and provide your contact information as indicated in the portal. 6. If you may have further distributed the CHF-CB30S, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter. OMSC requests you to report any patient injuries associated with any OMSC endoscope. Call our Technical Assistance Center (TAC) at 1-800-848-9024, option 1 to report complaints. If you have any questions or concerns, please do not hesitate to contact me directly at 484-896-5688 or at laura.storms@olympus.com.
• Quantity in Commerce: 193 devices distributed in the U.S. 548 devices distributed globally.
• Distribution: US Nationwide Distribution in states of: AK, AZ, CA, FL, GA, IL, LA, MA, ME, MI, MN, MS, NC, NM, NJ, NY, OR, SC, TN, WA, and WI; and International to: Japan.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.