SpyScope DS Access and Delivery Catheter (2017-12-20)

Starting date:

December 20, 2017

Posting date:

January 29, 2018

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-65792

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  Reason
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  Affected products

Affected products

SpyScope DS Access and Delivery Catheter

Reason

Potential for these devices to not perform as intended. An internal investigation found that the working channel sleeve not be adequately bonded inside of these devices. This may result in the working channel sleeve protruding from the camera cap located at the distal tip of the catheter. The most common injury reported has been minor tissue damage caused by the protruding working channel sleeve scraping along the duct walls during the procedure.

Affected products