FDA Defines DaVinci S.P. Robotic Surgery System Recall as Class 2
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) declared that the DaVinci S.P. robotic surgery system produced by medical device manufacturer Intuitive Surgical as a Class 2 recall. The company determined that a phenomenon it calls a “software anomaly” would vibrate the instrument’s tips and endoscope during surgery, according to an article appearing in Becker’s Hospital Review. The FDA defines a Class 2 recall as one in which the use or exposure of other patients to a malfunctioning product could cause a temporary or a medical condition that can be reversed or the patient can be healed. In contrast, a class one recall is one in which medical device threatens the health and safety of the patient because the device could inflict a permanent injury or kill the patient.
The robotic device manufactured by Intuitive Surgical rarely malfunctions according to a statement from the company. The company did not describe the health risk that the vibrating robotic surgery arm could cause a surgical patient.
The FDA notes that a Class 2 recall could cause a significant injury to the patient. However, The FDA notes that the occurrence of serious injuries inflicted by medical devices subject to a Class 2 recall is rare.
The FDA did not order Intuitive Surgical to remove the potentially defective surgical robots from operating rooms. Instead, Intuitive Surgical scent several instructions detailing how emergency measures will stop the vibrations caused by the software problem.
The surgeon operating the machine could take several steps to stop the vibration. The Intuitive Surgical instructions indicate that surgeons should stop using sustained force on the hands of the robotic arm, exit the program by releasing a control panel, step out of the surgical console, or press the emergency stop button.
Surgeons are also instructed to discontinue use if the vibration does not stop despite taking the measures as instructed. The surgical staff is also instructed to contact a representative of Intuitive Surgical to assist with repairs and Technical Support.
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