Surgical staplers are medical devices often used to close wounds during surgery, both internally and externally. Surgical staplers are commonly used for gastrointestinal surgeries, including bowel resections, colorectal cancer surgeries, bariatric surgeries, and other conditions. When a surgical stapler malfunctions during use in an internal surgery, there may be significant consequences including serious injuries or death. Surgical stapler malfunctions include:
- failure to fire necessary staples, which may fail to properly close the wound/incision and result in bleeding or leakage from that opening;
- failure to properly “close” the staple/firing a malformed staple, which may fail to properly close the wound/incision as noted above, as well it may injure nearby organs or tissues, or function as a site for infection;
- and firing a staple into adjacent organs or tissues.
Surgical stapler recalls
There have been multiple recalls in Canada for surgical staplers manufactured by Ethicon, a Johnson & Johnson subsidiary, and Covidien, a Medtronic subsidiary. In the past four years, Health Canada has published at least ten recall notices, and in the United States, there have also been numerous recalls involving surgical staplers.
List of Covidien and Ethicon surgical stapler recalls in Canada as of June 2022
- Eea Autosuture Circular Stapler With Dst Series (2022-05-16)
- TA AUTOSUTURE VASCULAR STAPLER WITH DST SERIES TECHNOLOGY (2020-11-26)
- Endo GIA Autosuture Universal Loading Unit Articulating (2020-08-18)
- Multifire VersaTack Auto Suture Hernia Stapler 4.0 mm and Multifire VersaTack Auto Suture Hernia Stapler 4.8 mm & Multifire Endo Hernia Auto Suture Straight Hernia Stapler12mm – 4.8 mm and Multifire Endo Hernia Auto Suture Straight Hernia Stapler12mm – 4.0 mm (2020-05-15)
- Endo GIA: Ultra Articulating Sulu w/Tri-Staple Technology Med/Thick and Med/Thick Dissect, Reload w/Tri-Staple Technology Med/Thick, Curved Tip Reload w/Tri-Staple Technology Medium/Thick (2019-05-16)
- PROXIMATE ILS Intraluminal Stapler, Endopath ILS Endoscopic Circular Stapler (2019-03-28)
- PROXIMATE HCS Hemorrhoidal Circular Stapler and PROXIMATE PPH Procedure for Prolapse and Hemorrhoids Set (2018-12-11)
- Endo GIA Reload w/Tri-Staple Technology Med/Thick, Endo GIA Curved Tip Reload w/Tri-Staple Technology Vascular and Vascular/Medium, and Endo GIA Gray Articulating Reload Extra Thin/Vascular (2018-05-23)
- Covidien Endo GIA Articulating Loading Units (2018-04-26)
- EEA Hemorrhoid and Prolapse Stapler Set with DST (2018-04-09)
U.S. Food and Drug Administration (FDA) regulatory action
In May 2019, the US Food and Drug Agency issued a Class 1 recall, the most serious type, for Ethicon’s Circular Staplers following reports that the medical devices caused serious harm or death. In October 2021, the FDA reclassified “surgical staplers for internal use” under more strenuous safety standards – establishing additional, new “special controls” (including increased testing and labelling requirements for surgical staplers) and requiring premarket review to provide a reasonable assurance of safety and effectiveness for these devices.
Complications from medical staples after surgery
Complications following a surgery or procedure with a surgical stapler may be severe and life threatening, including:
- anastomotic leak (spillage of contents where the wound was not properly closed);
- infection;
- fistulas;
- sepsis;
- multi-organ system failure;
- severe bleeding;
- need for a permanent ostomy bag;
- organ and tissue damage;
- additional surgeries;
- additional closures (anastomoses);
- or death.
To hear from patients impacted by surgical stapler malfunctions, watch the CTV Health News story: Class-action lawsuit alleges surgical staples failed and caused further complications.
Covidien and Ethicon surgical stapler class action
Siskinds has commenced class action litigation against Covidien and Ethicon in relation to these surgical stapler devices, on behalf of Canadians who have suffered serious injuries and complications arising after staples were used in a surgery.
If you or someone you know has experienced a complication from a surgical stapler procedure, contact our team of experienced medical product and health law lawyers. Please email [email protected] or call us toll free at 1-800-461-6166.