Injuries Caused by Tiger Paw Surgical Stapler
Maquet Medical Systems is a manufacturer of medical devices, including the Tiger Paw System II. The Tiger Paw System II is a surgical staple device used to close tissue in a patient’s heart and is often used during open-heart surgery. Unfortunately, serious complications have been reported with the use of this device. Patients have reported tears in the heart, as well as bleeding in the heart tissue and other complications.
If you are experiencing complications after heart surgery, and believe the Tiger Paw System II was used, you may be entitled to compensation. One of our personal injury attorneys can review your case to see what Contact us today to schedule your free consultation.Recall of the Maquet Medical system Tiger Paw System II
In 2015, the Food and Drug Administration (FDA) issued an urgent medical device recall for the immediate removal of the TigerPaw System II. The FDA stated that the reason for the recall involved possible issues with tissue tearing, which could cause the walls of the heart not to close completely. Specifically, the FDA recalled the following parts:
- C-TP-1507 (7 connectors)
- C-TP-1509 (9 connectors)
Between April 1st, 2013, and March 23rd, 2015, over 4,000 Tiger Paw System II staplers were distributed to 223 different medical facilities. Soon after, the manufacturer received over 50 different reports of adverse complications; one patient died from the stapling device’s alleged complications.
Patients reported tearing of their left atrial wall which is located in the left chamber of the heart. It was alleged that the Tiger Paw System II did not completely close, instead of closing the sutures in the heart effectively, these devices allegedly kept the laceration open, not allowing the site to heal properly.
When the FDA gives a Class 1 designation along with a recall, it means that the recalled product is capable of causing severe harm to patients. Typically, when the FDA issues a Class 1 recall, the medical device in question has been associated with life-altering or fatal injuries. The FDA instructed surgeons to quarantine or remove all TigerPaw System II devices. They also instructed surgeons, medical providers, and hospitals to place Tiger Paw System II devices in a secure location until the FDA issued further notice.Injuries Caused by the Tiger Paw System II
Since then, more injuries connected to Tiger Paw System II devices have been reported. Patients who underwent surgeries where the Tiger Paw System was used, reported serious complications, and dangerous injuries to their hearts. Some reported that the TigerPaw System II staples tore the atrial wall of their heart, causing internal bleeding.
In other cases, the device failed to seal the patients’ left atrial appendages. The failure to seal allowed blood clots to form within the patients’ hearts, rendering the heart surgery ineffective. Patients have reported the following complications related to the Tiger Paw System II:
- Tears in the atrial wall, or at the site of the sutures, causing internal bleeding
- Blood clots formed in the heart
- Infections due to torn tissues and bleeding
- Heart failure caused by infection or bleeding
If you or a loved one believe to have suffered injuries caused by the Tiger Paw System II stapler device, you may be entitled to compensation from the product manufacturer. Maquet Medical Systems manufactured these devices starting in 2013.
Under North Carolina law, product manufacturers and retailers have a duty to sell reasonably safe products. They must also provide warnings to patients regarding the potential dangers associated with their products. When device manufacturers fail to create a reasonably safe product or fail to provide adequate warnings, those injured by their products may have a right to bring a lawsuit against the manufacturer or retailer of the defective device.Contact Us Today
If you believe you have experienced complications related to the use of the Tiger Paw II system, it is important to contact an attorney who can help with potential legal options. At Arnold & Smith, PLLC, we understand how overwhelming it can be to deal with a potential lawsuit on top of health complications, and we are here to help. Our team of personal injury lawyers can evaluate the circumstances of your case and advocate for you. Contact us today to schedule your free consultation.
For your convenience and safety, we offer video and phone conferencing. If you prefer an in-person consultation, we have three easy to reach offices in Uptown Charlotte, Monroe, and Mooresville.