Single Use Suction Valve (2019-04-05)

Starting date:

April 5, 2019

Posting date:

December 6, 2019

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-71810

Last updated: 2019-12-06

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  Reason
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  Affected products

Affected Products

Single Use Suction Valve

Reason

Olympus received complaint regarding recalled device breaking during a patient procedure. Valve remained stuck inside the bronchoscope's instrument channel port resulting in an extended patient procedure and prolonged patient exposure to anesthesia.

Olympus determined the product to be safe for use in accordance with the device instruction for use. Olympus is notifying customers on the possibility of breakage, proper handling and how to disassemble broken device from an endoscope should breakage occur in an addendum.

Affected products