Device product
Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Z-3017-2020
Product summary
- Event
- Event 86384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,813 devices distributed worldwide, including 2,648 devices distributed throughout U.S.A.
- Official record key
device-enforcement:Z-3017-2020
Official wording
Reason: The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes.
Code information: All serial numbers
Distribution pattern: Worldwide distribution - US Nationwide and International.
Derived failure modes
-
Unknown
The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes.