PENTAX Video Duodenoscope (2018-02-20)

Starting date:

February 20, 2018

Posting date:

February 22, 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-66034

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  Reason
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  Affected products

Affected products

PENTAX Video Duodenoscope

Reason

In March 2017, as part of field action 2017-001-c, Pentax Medical informed customers about a potential cracks and gaps in the distal cap of the ED-3490TK, and instituted a distal cap inspection program. During discussion with the US FDA as part of this field action, Pentax Medical agreed to redesign the ED-3490TK's forceps elevator mechanism, O-Ring, and Distal End to reduce the risk of cross-contamination resulting from body fluids entering portions of the ED-3490TK that cannot be easily cleaned.

Affected products