Endo GIA Autosuture Universal Loading Unit Articulating (2020-08-18)

Starting date:

August 18, 2020

Posting date:

September 4, 2020

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-73863

Last updated:
2020-09-04

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  Reason
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  Affected products

Affected Products

Endo GIA Autosuture Universal Loading Unit Articulating

Reason

This voluntary recall is being conducted following receipt of one confirmed customer report that the device staples were not properly formed upon application preventing adequate hemostasis. Our investigation identified a potential for a manufacturing assembly error that can contribute to staple malformation. The affected devices were distributed between June 2017 and July 2020. Use of a product with this assembly error may result in incomplete staple formation. In   thoracoscopic/laparoscopic cases, this could cause significant hemorrhage including hemothorax and hemoperitoneum potentially requiring an urgent conversion to open surgery. The potential also exists for bleeding, anastomotic leak, pneumothorax or other delayed secondary complications including infection, peritonitis, sepsis and an increased risk of mortality. Manufacturing process improvements have been implemented to remediate this issue.

Affected products