—#183489

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).

FDA product code: FBN — Choledochoscope And Accessories, Flexible/Rigid
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: All lot codes..

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-08-31
Terminated: 2022-12-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183489. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.