Category: Medical Devices
Texas Stryker ShapeMatch Cutting Guide Lawyer
UPDATE: OtisMed Guilty of Selling Unapproved Knee Implant Cutting Guides December 11, 2014 — The FDA has announced that the former CEO of OtisMed Corp. has been convicted of criminal charges involving the distribution of unapproved orthopedic cutting guides for...
Texas Game Ready Lawyer
The Game Ready Cold Therapy System is a medical device that applies continuous freezing-cold temperatures to injured body parts through a compression pad. Unfortunately, patients who use the product may become numb and fail to realize they they are suffering...
Texas DonJoy Iceman Lawyer
The DonJoy Iceman is a cold therapy machine (sometimes called “cryotherapy” or “ice therapy”) that consists of an ice-chest that pumps freezing-cold water into a compression pad. Unfortunately, over several hours, it may desensitize nerves and patients may fail to...
Texas Breg Polar Care Lawyer
The Breg Polar Care (also known as a cold therapy machine, ice therapy, or cryotherapy) is designed to reduce pain and swelling by delivering hours of ice-cold temperatures to an injured body part. Unfortunately, by deadening nerves, patients can easily...
Texas Cook Stent Recall Lawyer
Cook Medical Inc. has recalled a stent implant that is used to hold open arteries in the thigh of patients with peripheral artery disease. The Cook stent recall was initiated after the company received 13 reports of a defective catheter...
FDA has 4,600 Side Effect Reports for Da Vinci Surgical Robot
March 22, 2013 -- Citron Research, an independent think-tank group led by Andrew Left, has identified 4,600 adverse event reports associated with the Da Vinci Robotic Surgery System in the U.S. Food and Drug Administration (FDA) database, according to this...
Researchers Question IVC Filter Safety and Effectiveness
Experts are questioning the risks and benefits of IVC Filters.
“Aggressive and Misleading” Marketing of Robotic Hysterectomy
March 21, 2013 -- The Da Vinci Robotic Surgical System is frequently marketed for hysterectomies (removal of the uterus) with claims that it will provide a woman with a “better overall experience.” The additional benefits of a robotic hysterectomy are...
Robotic Surgery is Not Best for Hysterectomy: OB/GYN Expert
March 21, 2013 -- The president of the nation’s organization of obstetricians and gynecologists has warned that robotic surgery is not the best way to perform a hysterectomy. Dr. James T. Breeden of the American Congress of Obstetricians and Gynecologists...
FDA Reports of Da Vinci Surgical Robot Injuries
March 20, 2013 -- Ever since Intuitive Surgical received approval for the Da Vinci Surgical Robot in 2000, a growing number of people have reported serious adverse events to the U.S. Food and Drug Administration (FDA). Although Intuitive Surgical recently...