24 year-old Kimberley McCalla was supposed to have a hysterectomy, which involved the removal of her uterus. But, her father says she suffered bleeding into her pelvis from a laceration to an artery during her robotic-assisted surgery.
“Blood was flowing from between her legs,” her father, Gilmore McCalla, told CNBC. “Two nurses were there around her, catching the blood in a bottle.”
She passed away 13 days after her first surgery.
McCalla’s father is suing Intuitive Surgical, the maker of the da Vinci robot, who says she died as a result of injuries sustained by use of the da Vinci robot.
Cases against the da Vinci robot are growing. Shawn Todd, of Mobile, Ala., thought she was having a routine partial hysterectomy. Sonya Melton of Birmingham, Ala. was also expecting a same-day surgery to treat uterine fibroids. However, both Todd and Melton were hospitalized for weeks from complications from their surgeries involving the da Vinci robot.
The lawyer who represents Todd and Melton claims that his clients’ injuries were not apparent right after surgery. He says his clients suffered burns by Intuitive’s use of monopolar energy. This energy applies high-frequency electric current to biological tissue to: cut, coagulate, or desiccate it.
While Intuitive Surgical declined to discuss the above cases due to pending Da Vinci Robot lawsuit, they have tried to alleviate the situation by introducing new tip covers. According to CNBC, Intuitive introduced a replacement to its “tip cover accessory” for da Vinci’s monopolar instruments. Intuitive also asked hospitals “to begin using” the new tip cover “immediately.” Lastly, they requested hospitals acknowledge the receipt of the letter and to return the older model for credit.
In an attempt to explain their actions, Intuitive said: “We invented a new bonding process that allowed production of a more robust tip cover. The original tip cover was not deemed defective; however, the company replaced existing customer stock with the new tip covers when they became available.”
However, Dr. Younes Bakri, director of gynaecologic oncology at West Virginia University and a robotic surgeon, created a video that shows that the new tip cover still produces arcing, which he says can still burn tissue. In response to the video, Intuitive claimed that if operated in the same manner, the burning would still occur in a non-robotic surgery.
Since 2000, there have been at least 85 deaths and 245 injuries related to the da Vinci robot. Last year, the number of procedures that used the da Vinci neared half a million.
Dr. Marty Makary of Johns Hopkins University Hospital, a pancreatic specialist who is trained on the da Vinci, prefers non-robotic surgery due to the lack of tactile feedback. He explains that because he works around major blood vessels, an accidental injury can cause enormous bleeds in seconds.
In February, the FDA launched a probe calling for information from hospitals using the da Vinci. Additionally, in March, the American Congress of Obstetricians and Gynaecologists warned that there is a learning curve with new surgical technologies, during which there is an increased complication rate. Five days later, the Massachusetts Board of Registration in Medicine stated that more patient reports are citing complications associated with robotic-assisted surgery.