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Jim Lewis
Jim Lewis
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Da Vinci Robot Risks Spurs FDA Investigation

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Serious complaints regarding the da Vinci surgical robot have resulted in an investigation by the FDA. The cost of the procedure, as well as its tangential benefit to the patient, have caused the FDA to attempt to decrease complaints associated with the medical device and increase medical training in order to ensure safe and proper methods of surgical care.

The da Vinci robot’s popularity has skyrocketed due to its being marketed as extremely non-invasive and incredibly effective in doing surgery. Some of the most common procedures for which it is used are cardiac valve repair, gynecological surgeries and prostatectomies. Though its use is becoming more frequent, there are critics who claim that the device has a steep learning curve in using it, along with a lack of indication that the procedures have any more long-term benefit than standard, non-robotic surgery.

Synim Rivers, a spokeswoman for the FDA, reported that the robot surgical device came under investigation after numerous complaints were received from patients who utilized the Da Vinci system in their surgeries. “Since it is difficult to know why the reports have increased, “ she wrote, “FDA has elected to talk with surgeons to better understand the factors that may be contributing to the rise in report numbers…We are conducting a survey with a small sample of surgeons who used the da Vinci Surgical System”

Intuitive Surgical, the manufacturer of the da Vinci device, claims that the reported failures and complaints are due to minor instrument malfunctionsthat can be fixed easily. However, the serious nature of the machine’s errors call this excuse into question: there are reports of the machine randomly cauterizing internal organs, for instance, or damaging heart tissue. Such complaints necessitate a critical evaluation of the machine’s efficacy.

There are also serious reports of the da Vinci robot’s being aggressively marketed to hospitals, which may have lead to patient injuries. For instance, a sales rep claimed that a hospital’s safety procedures regarding the machine were too stringent and should be relaxed. Such encouraged carelessness is inexcusable for a company that is responsible for such a high level of patient safety. An investigation by the FDA is the correct course of action at this point.