Reported Adverse Effects Associated with the da Vinci Surgical System

The introduction of the da Vinci Surgical System in the year 2000, after the US Food and Drug Administration approved its use for minimally invasive operations, is a major advancement in the area of surgical procedures. The device’s capability to make tiny incisions accurately and with great precision, as well as eliminate the possibility of infection on the surgical site, are factors any surgeon ought to recognize.

Despite the claims of Intuitive Surgical Inc., the manufacturer of the da Vinci, that the device is safe and technically sound, claims of adverse effects continue to rise and accusing fingers all point to the da Vinci as the cause. The da Vinci Surgical System is actually a multi-armed surgical machine that was designed to help surgeons around the world perform minimally invasive surgeries with the highest rates of success.

The machine is now being used in Europe, Japan and in a majority of the hospitals across the US. In 2012 more than 300,000 surgeries (using the device) were performed in the US; adding the numbers from other parts of the globe, the total would reach at least half a million. Intuitive Surgical Inc. proudly claims that those procedures have been carried out successfully.

During surgery, a surgeon, who is seated some feet away from the patient, takes control of the da Vinci. The device provides him/her with a magnified 3D image of the surgical site. He/She operates the robot’s arms using a console. Each arm holds an instrument, including an endoscope (a tiny camera). The multiple tiny incisions made by the surgeon are just big enough for the endoscope and the instruments to penetrate the patient’s body. These incisions, which are a few millimeters in length (as contrasted to open/traditional/invasive surgery where 4-inch incisions are sometimes made), mean lesser pain, reduced blood loss and faster healing.

A research headed by surgeon Dr. Martin Makary at Johns Hopkins, however, claims of coming across unreported incidences of deaths due to the device. The FDA too has received reports of about 245 adverse effects caused by the da Vinci system. But whether it is really the machine at fault or the surgeon due to lack of training and familiarity with the machine, the issue is yet to be settled.

Some of the issues reported regarding the ill-effects to patients during surgeries, include:

  • Mechanical failure before the start of the surgery
  • Puncture on the colon during prostatectomy
  • Death of a patient after a spleen surgery
  • Death of a patient during a hysterectomy due to an accidental of a blood vessel
  • A robot’s arm accidentally hitting a patient’s face
  • Internal bleeding, infection, burns and tears

Despite these reports patients who need to undergo surgeries continue to flock hospitals where there is a da Vinci device. Likewise, many surgeons continue to laud the machine, which ensures greater precision and a clearer visibility.

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