- IVC Blood Clot Filter Lawsuit
- JUUL Addiction Lawyers
- Surgical Stapler Lawsuit
- Effexor Birth Defects Lawsuit
- GM Ignition Switch Recall Lawsuit
- Vaginal Mesh Lawsuit
- Avaulta Mesh Lawsuit
- 3M Bair Hugger Lawsuit
- X-LITE Guardrail Lawsuit
- Durata Lead Problems
- DePuy Pinnacle Hip Replacement Lawsuit
- DePuy Hip Implant Recall
- Artelon Spacer Problems
- Caldera Medical Mesh Lawsuit
- Breast Implant Lymphoma Lawsuit
- Invega Gynecomastia Lawsuit
- Coloplast Mesh Lawsuit
- Zimmer Biomet Hip Replacement Lawsuit
- Medtronic Defibrillator & Pacemaker Heart Device Recall
- Gynecare Vaginal Mesh Withdrawn
- Mirena IUD Information
- Smith and Nephew Hip Liner Recall
- SSRI Lawsuits
- Peter Pan and Great Value Peanut Butter Contamination
- Shoulder Pain Management Pumps
- OtisKnee Replacement Lawsuit
- Bard Mesh Lawsuit
- Wright Conserve Hip Replacement Lawsuit
- Medical Food Generics
- Tyco Lawsuit
- Mario Badescu Lawsuit
- Synthetic Marijuana Lawsuits
- Zimmer Knee Replacement
- CertainTeed Shingles Lawsuit
- BEHR DeckOver Lawsuit
- Waupaca Elevator Recall Lawsuits
- Sunscreen Recall Lawsuit | Benzene Lawsuit
- What Are the Criteria for a Talcum Powder Lawsuit?
- What Should I Do if My 3M Earplugs Don't Work?
- The Boppy Pillow Recall Lawsuit
- One-Wheel Skateboard Lawsuit
- Monsanto Roundup Lawsuit
- Talcum Powder Lawsuit
- 3M Earplug Lawsuit
- What Does Product Liability Mean to Me?
- Baby Formula NEC Lawsuit
- Baby Formula Enfamil Lawsuit
- Baby Formula Similac Lawsuit
- Hernia Mesh Lawsuits
- Monster Energy Lawsuit
- Sunscreen Recall Lawsuit | Benzene Lawsuit
- Takata Airbag Recall
- Philips CPAP & Sleep Apnea Machine Lawsuit
- Stryker Hip Replacement Recall Lawsuit
- CertainTeed Shingles Lawsuit
- Types of Torts | Mass Tort Information
- Johnson & Johnson Class Action Lawsuit
- Does Taxotere Cause Hair Loss?
- Mini Cooper Timing Chain Recall: What You Need to Know
- Where Can I Find Support for My Mass Tort Case?
- Do I need an Attorney for My Roundup Claim?
- What Is the Latest News on Johnson & Johnson's Talcum Powder Lawsuit?
- What Is the CPAP Machine Lawsuit Process?
- How to File a Lawsuit for a CPAP Machine
- Are ResMed CPAP Machines Being Recalled?
- Is There a Class Action Lawsuit Against Phillips CPAP Machines?
- When Should I Sue for Product Liability?
- What Are Some Signs That You Have a Product Liability Case?
- Does Talcum Powder Cause Ovarian Cancer?
- Can You Sue a Birth Control Company After Getting Pregnant?
- Can Lithium Batteries Explode?
- What Is the Average Johnson & Johnson Baby Powder Settlement?
- What Types of Cancers Can Be Caused by RoundUp?
- What Does "Tort Law" Mean in the Legal Industry?
- Where Can I Find Lawyers Who Handle Mass Tort Issues?
- What Do I Need to Know About Popcorn Lung Disease Litigation?
- Abbott Baby Formula Recall
- Where Can I Find the Best One-Wheel Skateboard Accident Lawyer?
- Popcorn Lung Disease Lawsuits
- Toxic Baby Formula Lawsuit
Da Vinci Robotic Surgery
There have been an increasing number of complaints of complications, including burns, punctured vessels or organs, excessive bleeding and deaths, which are believed to be associated with the use of the da Vinci surgical robot during surgery. In response to the rise in complaints and concern over the safety of its use, the FDA has launched an investigation to determine whether Intuitive Surgical, Inc.’s device is responsible for the allegations in the complaints.
Manufacturer Warns of da Vinci Burn Risk
In May 2013, Intuitive warned hospitals that a component used in its da Vinci surgical robot system may be putting patients at risk for burn injuries. According to the company’s urgent notification, some versions of the system’s Hot Shears may be prone to small cracks, potentially creating a pathway for an electro-surgical charge. Unfortunately, the cracks may not be visible. The company has already received one report of injury linked to a cracked instrument. Despite the risk, the company has elected not to recall the Hot Shears and announced that it would begin to remove the affected instruments from hospitals when a replacement becomes available. It is estimated that this will begin between two to four weeks from the date of the company’s notification.
Uses of the da Vinci Surgical Robot
The da Vinci surgical robot, manufactured by Intuitive Surgery, is an alternative surgical method to laparoscopic procedures and has increasingly gained popularity with hospitals since its FDA approval in 2000.
The robot is designed to perform minimally invasive surgery in procedures including urologic, laparoscopic, gynecological and non-cardio theracoscopic surgical procedures.
Some examples in which the robot has been chosen over its alternative procedure, laparoscopic surgery, include:
- Complete or partial hysterectomies
- Treatment of uterine fibroids
- Kidney disorders
- Prostate removal procedures
- Throat and kidney cancers
- Heavy intrauterine bleeding
- Surgeries to reduce obesity
It is often chosen by hospitals and doctors over laparoscopic surgery due to Intuitive’s claims that the procedure is as safe as laparoscopic surgery, yet reduces recovery time in patients.
There have been no conclusive studies showing the da Vinci robot is a better or safer choice for doctors performing minimally invasive procedures—in fact, there are many signs that indicate its negative attributes outweigh its benefits.
Costs of the robot significantly outweigh those of laparoscopic surgeries, surgery takes longer, and recovery times have not been proven to be substantially shorter than other similar procedures. Additionally, there have been no conclusive studies that the robot is a safer or better choice than other minimally invasive procedures. A study being released soon blames a lack of testing prior to distribution for many of the complications which have arisen.
Allegations and Complaints
Despite the popularity of the da Vinci surgical robot, the number of complaints concerning complications stemming from the use of the device have been on the rise.
Complaints against the manufacturer allege design flaws in the device including un-insulated surgical arms that cause burns, as well as electrical currents that can deviate from the intended surgical route to healthy organs and tissue, damaging them in the process.
Additionally, the complaint alleged the manufacturer of failing to warn healthcare professionals and potential patients of the risks that can be involved in its use.
Complications or errors that have been referred to in lawsuits and through witness interviews include:
- Punctured vessels or organs
- Uterus lacerations
- Intestinal tearing
- Excessive bleeding
Unfortunately, complications from the surgery may not be evident until days after the procedure is completed, which uses up valuable time which could be used to treat the injury.
Some reports of life-threatening or deadly complications include:
The death of a woman 13 days after a procedure using the device during a routine hysterectomy. The parents of the woman claim she suffered bleeding from the laceration of a main artery by the robot during surgery, which caused blood to flow from and between her legs, requiring nurses to catch the blood in bottles.
Two women were hospitalized for weeks after what was supposed to be “routine” gynecological surgery involving a da Vinci robot.
A girl suffered severe internal burns to her intestines and an artery during a routine hysterectomy. She died two weeks later, prompting her parents to file a wrongful death lawsuit.
Response to da Vinci Safety Complaints
Intuitive, taking an unprompted step to mitigate the situation, sent replacement tip covers to all hospitals with the device. While the original tips were not deemed defective, the company requested the switch from the existing tips immediately to reduce the chance of sparking. However, surgeons who have observed the use of the device do not believe the tip of the robot to be a problem.
Instead, their observations led them to believe the burns stems from the scissor blade. Intuitive stands firm in their belief that the da Vinci device is no more dangerous than traditional laparoscopic devices, which they claim could cause similar issues during surgery.