Endocuff Vision (2020-04-16)

Starting date:

April 16, 2020

Posting date:

May 8, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-73009

Last updated: 2020-05-08

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  Reason
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  Affected products

Affected Products

Endocuff Vision

Reason

Boddingtons, the manufacturer is notifying customers regarding the update to an IFU for Endocuff Vision model numbers ARV110, ARV120, ARV130, and ARV140. The new IFU will include the following information relating to contraindications and potential complications/adverse events of the colonoscopy procedure.

Contraindication: the Endocuff Vision should not be used in cases with acute, severe colitis, diverticulitis or where there is known colonic stricture.

Potential complication or adverse events: no common adverse events or complications for Endocuff Vision are known. However,

potential complications related to colonoscopy include, but are not limited to perforation, bleeding, infection, discomfort and allergic reaction to sedation agents.

Boddingtons has determined that customers may continue to use products on hand provided users are aware of the updated information. The updated IFU will accompany new products starting in May 2020.

 

Affected products