Recall Z-0119-2021 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
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).
| Date | Aug 31, 2020 |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.