Device product

Olympus JF-160F duodenoscopes (Model NumberJF-160F)

Z-2270-2018

May 11, 2018

Class II

Product summary

Firm: Olympus Corporation of the Americas
Event: Event 79998
Status: Terminated
Classification: Class II
Quantity: 68
Official record key: device-enforcement:Z-2270-2018

Official wording

Reason: Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.

Code information: All

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.