OES CHOLEDOCHOFIBERSCOPES (2020-08-26)

Starting date:

August 26, 2020

Posting date:

September 4, 2020

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-73865

Last updated:
2020-09-04

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  Reason
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  Affected products

Affected Products

OES CHOLEDOCHOFIBERSCOPES

Reason

Olympus Medical Systems Corporation conducted a post-market risk assessment regarding an adverse event involving CHF-CB30S which showed that this device has been associated with breakage of the insertion section and protrusion of metal parts, as well as breakage and displacement of the rubber on the bending section during surgical procedures. Olympus will be withdrawing the product from the market due to unacceptable risk.

Affected products