Device product

BF-3C160: EVIS EXERA Bronchovideoscope

Z-1047-2022

March 08, 2022

Class II

Product summary

Firm: Olympus Corporation of the Americas
Event: Event 89942
Status: Ongoing
Classification: Class II
Quantity: 1052 units
Official record key: device-enforcement:Z-1047-2022

Official wording

Reason: Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

Code information: All serial numbers. UDI: 04953170340031

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization