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EVIS EXERA VIDEO SYSTEM - DUODENOVIDEOSCOPES (2016-04-18)
- Starting date:
- April 18, 2016
- Posting date:
- April 29, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-58160
Affected Products
EVIS EXERA VIDEO SYSTEM - DUODENOVIDEOSCOPES
Reason
Manufacturer is issuing validated, new reprocessing instructions for the Olympus TJF-160F /VF duodenoscopes ("TJF-160F /VF"), consisting of revised manual cleaning and high level disinfection procedures.
These new reprocessing procedures should be implemented as soon as possible. The new cleaning procedure requires the use of a new cleaning brush (MAJ-1534).
In addition to the new cleaning brush referenced above, the new TJF-160F /VF reprocessing procedures require additional flushing and forceps elevator raising/lowering steps during precleaning and manual cleaning, manual disinfection, endoscope rinsing and alcohol flushing.
Affected products
EVIS EXERA VIDEO SYSTEM - DUODENOVIDEOSCOPES
Lot or serial number
All lots.
Model or catalog number
TJF-160F
TJF-160VF
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN