SURGICAL STAPLER
Surgical Stapler Injuries and Complications
Wright McCall is investigating and filing claims on behalf of people across the United States who have suffered severe injuries and/or complications as a result of Surgical Staplers for Internal Use. If you or a loved one has died or suffered severe surgical complications as result of a surgery involving a surgical stapler or staples for internal use, please contact us for a free consultation.
FDA’s Warning Letter
In March of 2019, the FDA notified doctors that it is “concerned by the increasing number of adverse events associated with surgical staplers and staples for internal use and is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with these devices.”
“Because surgical staplers and staples for internal use are used as a system, the FDA analyzed the medical device reports submitted for both surgical staplers and implantable staples to obtain a comprehensive picture of the safety profile for these devices. Our analysis, which is ongoing, found that 2011 to 2018, the FDA received over 41,000 individual medical device reports for surgical staplers and staples for internal use, including:
- 366 deaths,
- over 9,000 serious injuries, and
- over 32,000 malfunctions.”
Some of the most commonly reported problems in these adverse event reports include:
- misfiring,
- difficulty in firing,
- failure of the stapler to fire the staple,
- misapplied staples (e.g., user applying staples to the wrong organ or tissue or applying staples of the wrong size to the tissue), and
- opening of the staple line or malformation of staples.
Stapler and/or staple malfunctions or misuse may result in severe surgical stapler complications, such as prolonged surgical procedures or unplanned, additional surgical procedures and operations, which may lead to other complications, such as:
- bleeding,
- sepsis,
- fistula formation,
- tearing of internal tissues and organs, and
Can I File a Surgical Stapler Lawsuit?
Our law firm can help determine whether you can file a lawsuit for selling defective Surgical Staplers and Staples for Internal Use and the failure to warn doctors and patients about their risks.
How Can DWM Help Me?
If the Surgical Stapler lawsuit is successful, you may be entitled to collect compensation for current and future medical expenses related to the defective device and the failure to warn of its risks, as well as for pain, suffering, disability, impairment, loss of enjoyment of life, and for lost income and wages.
SURGICAL STAPLER INFORMATION LINKS
Medtronic Facing Litigation over Surgical Staplers and Injury Reporting (1-10-2020)
http://www.startribune.com/medtronic-facing-litigation-over-surgical-staplers-and-injury-reporting/566855262/
J&J Recalls Surgical Tool after Patient Death, Serious Injuries (10-31-2019)
https://www.bloomberg.com/news/articles/2019-10-31/j-j-recalls-surgical-tool-after-patient-death-serious-injuries
These Surgical Staplers Linked to a Death and 7 Injuries have been Recalled (10-31-2019)
https://www.miamiherald.com/news/health-care/article236856873.html
Ethicon Recalls ECHELON FLEX™ ENDOPATH® Staplers for Failure to Completely Form Staples (10-3-2019)
https://www.fda.gov/medical-devices/medical-device-recalls/ethicon-recalls-echelon-flextm-endopathr-staplers-failure-completely-form-staples
Nearly 100,000 Ethicon Surgical Staplers Recalled (6-12-2019)
https://www.usrecallnews.com/nearly-100000-ethicon-surgical-staplers-recalled/
More Than Half of Surgical Stapler Malfunctions Went to Hidden FDA Database (5-30-2019)
https://khn.org/news/more-than-half-of-surgical-stapler-malfunctions-went-to-hidden-fda-database/
FDA labels Ethicon surgical staplers recall as Class I (5-20-2019)
https://www.medicaldevice-network.com/news/fda-ethicon-staplers-recall/
U.S. FDA Labels J&J Surgical Staplers’ Recall as Severest (5-17-2019)
https://www.reuters.com/article/us-johnson-johnson-recall/u-s-fda-labels-jj-surgical-staplers-recall-as-severest-idUSKCN1SN1T4
Ethicon Recalls Circular Staplers for Insufficient Firing and Failure to Completely Form Staples (4-11-2019)
https://www.fda.gov/medical-devices/medical-device-recalls/ethicon-recalls-circular-staplers-insufficient-firing-and-failure-completely-form-staples
Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers (3-8-2019)
https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm632938.htm
Hidden FDA Reports Detail Harm Caused by Scores of Medical Devices (3-7-2019)
https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/
FDA: Covidien 510(k) Premarket Notification (3-4-2019)
FDA: Ethicon 510(k) Premarket Notification (3-4-2019)
New Study Suggests Surgical Stapler May Play Important Role in Reducing Common Complication Associated with Lung Surgery (1-28-2019)
A Post Market Study to Confirm the Safety and Performance of the Signia Stapling System (1-25-2019)
https://clinicaltrials.gov/ct2/show/NCT03515811
Endo GIA Stapler Malfunction in a Small Bowel Loop Resection (10-26-2018)
https://academic.oup.com/jscr/article/2018/10/rjy281/5144975
U.S. Surgical Staplers Market by Product, Type and Application – Forecast to 2023 – ResearchAndMarkets.com (7-25-2018)
Medtronic Initiates Select Recall of Covidien Endo GIA Staplers (5-8-2018)
https://www.massdevice.com/medtronic-initiates-select-recall-of-covidien-endo-gia-staplers/
Looped Suture Versus Stapler Device in Pediatric Laparoscopic Appendectomy: A Comparative Outcomes and Intraoperative Cost Analysis (4-2018)
https://www.sciencedirect.com/science/article/pii/S0022346817303342
A Novel Approach to Assess Minimally Invasive Surgical Device Failure Utilizing Adverse Event Outcome Severity and Design Complexity (12-2017)
https://ir.library.louisville.edu/etd/2855/
Why Surgical Stapling is a Hot Medical Device Product (3-14-2017)
https://www.medicaldesignandoutsourcing.com/why-surgical-stapling-hot-medical-device-product/
Medtronic Profit Climbs as Covidien Deal Pays (3-1-2016)
https://www.marketwatch.com/story/medtronic-profit-climbs-as-covidien-deal-pays-2016-03-01
Ethicon Stapler Lawsuit Results in $80M Jury Award (12-16-2015)
https://www.aboutlawsuits.com/ethicon-stapler-verdict-91224/
Johnson & Johnson Hit with Extra $70 Million in Damages (12-16-2015)
https://www.mddionline.com/johnson-johnson-hit-extra-70-million-damages
Alexander Law Group, LLP Wins $70 Million Punitive Judgment Against Johnson & Johnson Subsidiary Ethicon Endo-Surgery (12-15-2015)
https://www.businesswire.com/news/home/20151214006468/en/Alexander-Law-Group-LLP-Wins-70-Million
Powered Stapler Malfunction During Laparoscopic Nephrectomy (2014)
https://pdfs.semanticscholar.org/2a14/226616eb40d9f14acfff28b7fc5af983be48.pdf
Surgical Stapling Device-Tissue Interactions: What Surgeons Need to Know to Improve Patient Outcomes (9-12-2014)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4168870/
Surgical Stapler Adverse Events in the Veterans Health Administration: Root Causes and Lessons Learned (7-22-2014)
https://journals.sagepub.com/doi/abs/10.1177/2327857914031025
Covidien Plans to Bring Back Recalled Duet TRS Surgical Stapling System (8-5-2013)
J&J Recalls Surgical Stapler Devices Over Safety Issue (10-26-2012)
https://www.wsj.com/articles/SB10001424052970204098704578080853291021898
Looking Past Recall, Covidien Gets 510(k) for Next-Gen Stapler (8-28-2012)
Covidien’s Surgical Stapler Recalled, Discontinued (8-24-2012)
https://www.outpatientsurgery.net/news/2012/08/24/covidien-s-surgical-stapler-recalled-discontinued
Covidien Withdraws Abdominal Stapler that had Less Than $50M in Sales in 9 Months (8-23-2012)
The Unacknowledged Incidence of Laparoscopic Stapler Malfunction (7-18-2012)
https://www.ncbi.nlm.nih.gov/pubmed/22806510
FDA Warns Covidien Over Surgical-Staple Deaths (6-27-2012)
https://www.bizjournals.com/boston/news/2012/06/27/fda-warns-covidien-over-surgical.html
FDA Chides Covidien on Handling of Surgical Staple Recall (6-27-2012)
https://www.massdevice.com/fda-chides-covidien-handling-surgical-staple-recall/
Staples Used in Thoracic Surgery Recalled (1-17-2012)
https://www.medpagetoday.com/productalert/devicesandvaccines/30712
Fatalities Prompt Recall of Staple Cartridge for Thoracic Surgery (1-17-2012)
https://www.medscape.com/viewarticle/756981
Covidien Recalls Surgical Staples After 3 Deaths (1-16-2012)
https://www.meshmedicaldevicenewsdesk.com/covidien-recalls-surgical-staples-after-3-deaths/
Patient Sues, Says Stapler Misfired in Surgery, Injuring Her (3-25-2009)
https://www.bendbulletin.com/news/1453845-151/patient-sues-says-stapler-misfired-in-surgery-injuring
Dangers in the Use of Staplers in Liver Surgery (11-2007)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2173167/
Dangers in the Use of Staplers in Liver Surgery (11-2007)
http://europepmc.org/articles/PMC2173167
Hemorrhoid Stapling Has More Long-term Risks Than Surgical Removal (10-22-2006)
https://www.sciencedaily.com/releases/2006/10/061018094723.htm
Surgical Stapler-Associated Fatalities and Adverse Events Reported to the Food and Drug Administration (9-2004)
https://www.ncbi.nlm.nih.gov/pubmed/15325606
Laparoscopic Linear Cutting Stapler Failure (9-2002)
https://www.sciencedirect.com/science/article/pii/S0090429502017788
Mechanical Vascular Division in Lung Resection (5-1-2002)
https://academic.oup.com/ejcts/article/21/5/879/507510
Stapled versus Sutured Gastrointestinal Anastomoses in the Trauma Patient: A Multicenter Trial (12-2001)
Postendoscopic Zenker Esophagodiverticulostomy Leaks Associated With a Specific Stapler Cartridge (8-30-2001)
https://jamanetwork.com/journals/jamaotolaryngology/fullarticle/482754
Bronchopleural Fistulas after Pneumonectomy. A Problem with Surgical Stapling (1987)