SYSTEM 83+ (2015-12-04)

Starting date:

December 4, 2015

Posting date:

December 22, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-56416

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  Reason
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  Affected products

Recalled Products

A. SYSTEM 83+

Reason

Update from the manufacturer on August 29, 2016: Custom Ultrasonic has extended the contraindications of System 83 Plus to include all duodenoscopes. The System 83 Plus should not be used for reprocessing any duodenoscope. The System 83 Plus Washer/Disinfector is intended to wash and disinfect endoscopes to mitigate the risk of patient infection. Inadequate validation and instructions for use could result in an increased risk of infection transmission. Other recommendations presented in previous safety notification still remain in effect. Please refer to the previous safety notification for details.

Update from the manufacturer on August 29, 2016: Custom Ultrasonics Automated Endoscope Reprocessors (AERs) should not be used for cleaning and/or high level disinfection of duodenoscopes. The device should not be used for cleaning and/or high level disinfection of any duodenoscopes until further written notice is provided by Custom Ultrasonics. This warning does not affect using the System 83 Plus on endoscopes other than duodenoscopes.

Update from the manufacturer on July 6, 2016: The Olympus Evis Exera 11 TJF 0180V Duodenoscope is contraindicated for use in the System 83 Plus (Washer/Disinfector). High Level Disinfectants Chemical Classes of Hypochlorite/Hypochlorous acid, Hydrogen Peroxide, and Peracetic Acid/Hydrogen Peroxide are contraindicated for use in the System 83 Plus (Washer/Disinfector). Custom Ultrasonics recommends that facilities implement a comprehensive water quality monitoring program.  Custom Ultrasonics is notifying customers in Canada to refer to the Operator’s manual for disinfection of the water filter assembly and to institute water quality monitoring. For more details contact the manufacturer.

Custom Ultrasonics Inc. Failed to complete validations of the Olympus Evis Exera II TJF Q180V Duodenocope processed in the System 83 Plus and the System 83 Plus 9 washer disinfectors and failed to complete validation of various high level disinfectants used with the System 83 Plus 2 and System 83 Plus 9 Washer Disinfectors.

Affected products