Operating microscope

FDA investigates Problems Encountered During Robotic Surgery

Operating microscopeWhat is often simply called “robotic surgery” should more accurately be referred to as either “robotic-assisted surgery” or “computer-controlled surgery”. However, even those terms are misleading. The robotic manipulators that perform the delicate maneuvers required for a successful surgical procedure will not move unless a surgeon is properly positioned at the controls.

Virtually every discussion of robotic-assisted surgery focuses on the da Vinci Surgical System, a minimally-invasive surgical system developed by Intuitive Surgical of Mountain View, California. Minimally-invasive surgery, made possible through advances in robotics, allows a surgeon to perform complex surgical procedures using very small incisions, resulting in much smaller, faster healing scars as opposed to the large incisions required for traditional surgery; for that reason, robotic surgery is very popular, even though it is the more expensive surgical option.

The Food & Drug Administration (FDA) is investigating possible problems with surgeries that were performed using the da Vinci system. Quoting an entry in a popular news blog, the Inquistir:

“An FDA database of reported problems related to the medical device [da Vince] generated nearly 500 reports filed since January 1, 2012. The reports include incidents which do not definitively prove the problems were caused by the robot, and many didn’t injure patients, but complaints were still filed.”

The nature of the incidents during surgery using the da Vince system include: leaving surgical implements and sponges behind after surgery and cases of accidentally nicked blood vessels and punctured organs. These types of complaints could theoretically be caused by equipment failure. However, considering that these types of problems also often occur during traditional surgery and are ‘traditionally’ caused by errors on the part of the surgeon or operating room staff, it seems responsible to consider either carelessness on the part of the surgeon controlling the robotics or possibly a lack of training as causative factors.

According to a study performed by the National Center for Biotechnology Information (NCBI) in an obstetrics/gynecology clinic over a 22 month period, surgeons using the da Vince surgical system did not reach optimal proficiency until having performing 50 surgeries.

There have, however, been documented problems with the da Vince surgical system itself. An April 9th article in the Cumberland County Sentinel discusses some of these problems and gives the views of some of the surgeons who use the da Vince surgical system.

Additional Reading:
http://www.ncbi.nlm.nih.gov/pubmed/18722971
http://www.tucsonnewsnow.com/story/21925556/fda-investigates-robotic-surgery-problems
http://cumberlink.com/news/local/fda-examines-robotic-surgery-after-hundreds-of-reports-of-problems/article_b10cc1c4-a168-11e2-9b08-0019bb2963f4.html
http://www.inquisitr.com/616822/fda-investigating-problems-with-da-vinci-surgical-technology