Device product
EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Z-2807-2015
Product summary
- Event
- Event 70858
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6109
- Official record key
device-enforcement:Z-2807-2015
Official wording
Reason: New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.
Code information: Model: TJF-Q180V, all sold units
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.
Derived failure modes
-
Unknown
New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.