Ultrasound Gastroscopes (2014-06-28)

Starting date:

June 28, 2014

Posting date:

July 10, 2014

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-40401

• Reason
• Affected products

Recalled Products

Ultrasound Gastroscopes

Reason

Pentax medical has been notified of a potential risk related to the use of certain models of ultrasound gastro scope listed above in combination with aspiration needles if the instructions for use document are not followed carefully by the user. Specifically, if the user fails to properly position the elevator while advancing the aspiration needles through the endoscope, then the needle can derail from the elevator. This could result in the needles not being visible in the endoscopic or sono- graphic field of view, leaving to the possibility of patient injury such as perforation.

Affected products