da Vinci Xi Robotic Heart Surgery Embolism Risk Draws New Warnings
The makers of the controversial da Vinci surgical robot are warning that some attachments may release particles during heart surgery, which could increase the risk of patients suffering a severe and potentially life-threatening embolism.
Intuitive Surgical issued an Urgent Product Safety Notice earlier this month, warning about the embolism risk during robotic heart surgery involving the da Vinci Xi 5 mm-8 mm Universal Seal and the da Vinci Xi 12mm & Stapler Universal Seal.
According to the warning, quality inspections found that the attachments could release particulates that could enter the heart during surgery.
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The da Vinci robot is a complex surgical device manufactured by Intuitive Surgical, which features a number of remotely controlled arms that are used to perform a number of different laparoscopic surgical procedures. While the device is found in many hospitals nationwide, this new warning is the latest in a number of da Vinci robotic surgery risks that have surfaced in recent years.
“Although there have been no injuries identified related to this issue, we are initiating this warning for use in intra-cardiac procedures due to the risk of foreign body embolism should particulates remain undetected and unintentionally left inside the heart,” the notice warns.
The notice indicates that the particulates could be as large as 1/8 of an inch in length, but has no sharp edges. The pieces are made of a bio-inert material known as HDPE, which is used in bone and cartilage implants.
The company is asking all of its customers to forward the warning to surgeons, risk managers, operating room directors, and any other medical staff who work with the da Vinci procedures.
While the company has not called the move a recall, it promises in the letter to notify customers when corrected products begin to ship and warned that supply may be limited. Such letters and warnings often result in an eventual decision by the FDA that the notices constitute a recall, but the FDA has made no such announcement yet.
Intuitive Surgical has previously faced hundreds of da Vinci robotic surgery lawsuits filed by individuals who experienced complications during procedures, many involving allegations that the manufacturer sold a dangerous and defective device, failed to adequately train surgeons and failed to provide adequate warnings for consumers about the risk of problems. The manufacturer has also faced a shareholder lawsuit by investors who say the company misrepresented the safety of the surgical robot.
In January 2013, a report by the investment research firm Citron Research highlighted a number of potential issues with the da Vinci robot and Intuitive Surgical’s response to those problems. Citron identified more than 4,600 adverse event reports submitted to federal health regulators involving the da Vinci robot, highlighting what the analysts described as a disturbing trend with the manufacturer making “clearly unfathomable” assertions that the complications had nothing to do with the da Vinci robot.
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