PROXIMATE ILS Intraluminal Stapler, Endopath ILS Endoscopic Circular Stapler (2019-03-28)

Starting date:

March 28, 2019

Posting date:

April 12, 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-69566

Last updated: 2019-04-12

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  Reason
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  Affected products

Affected Products

1. PROXIMATE ILS Intraluminal Stapler with detachable head
2. Endopath ILS Endoscopic Circular Stapler with low profile anvil

Reason

Through investigation of complaints and returned products, we have confirmed occurrence of uncut washers and malformed staples with our ILS circular staplers, which can compromise staple line integrity. If a problem with the staple line is not adequately addressed or is not recognized, there is a potential risk of postoperative anastomotic leak, gastrointestinal injury, hemorrhage, or hemorrhagic shock.

Affected products