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
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
Endo GIA Autosuture Universal Loading Unit Articulating
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 30450
- 30451
- 30452
- 30453
- 30454
- 30455
- 30457
- 30458
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES