Intuitive—da Vinci S, Si, and Si-e Surgical Systems: Friction within Patient Side Manipulator May Interrupt Smooth Instrument Motion
November 20, 2013 | Risk Management News
ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at email@example.com.
In a November 11, 2013, Field Safety Notice Urgent Medical Device Correction letter submitted by an ECRI Institute member hospital, Intuitive states that friction within the Patient Side Manipulators (instrument arms) on the systems below may interrupt smooth instrument motion and that this interruption may be felt by the surgeon as resistance in the movement of the Master Tool Manipulators (masters), potentially causing the instrument to stall momentarily and then suddenly catch up to the master position if the surgeon pushes through the resistance. Intuitive also states that this resistance is most noticeable when moving the instruments at very slow speeds and during small movements of the masters and that this system behavior is not autonomous instrument motion. Intuitive further states that it has received 3 reports of this problem occurring and that in one instance, the interrupted motion resulted in an imprecise cut during a planned transection of a urethra. Intuitive states that in that instance, the instrument remained in the surgeon's field of view and the surgeon subsequently modified the plane of transection and completed the procedure without further complications. Intuitive also states that in the other 2 instances, the imprecise...