Amid growing controversy about the da Vinci surgical robot, the device’s manufacturer, Intuitive Surgical, has issued a warning admitting to burn injuries it can cause patients.
Yet Intuitive stopped short of recalling the part of the robot that causes such burn injuries.
The warning issued by Intuitive was focused on the cautery scissors used with the surgical robot, which according to the company’s statement, have the potential to develop microcracks that can leak electrical energy and thus, inadvertently burn tissue.
The scissors, known as EndoWrist Hot Shears Monopolar Curved Scissors, are used to cut and coagulate tissue during various procedures, including hysterectomy, prostatectomy, and gastric bypass.
In its May 8 urgent notification, the company warns that the scissors may develop cracks that are not visible to the user. The cracks, according to the notification, may create a pathway for electrosurgical energy to leak and impact tissue and “potentially cause thermal injury.”
But rather than recall the scissors, the warning offers precautions regarding avoiding injury when using them and notes that users of the da Vinci surgical robot will be notified when scissors that do not have such cracking potential, will be available for replacement.
Only one injury has been reported to date, resulting from the cracked scissors, according to Intuitive. The company has notified the U.S. Food and Drug Administration (FDA) of the problem with the scissors.
According to a report in Medscape Medical News, Intuitive Surgical stated that replacement scissors should be available in 2 to 4 weeks.
Intuitive’s warning about the scissors comes on the heels of a spate of bad publicity for the company in recent months regarding the mounting number of injuries being reported in relation to the robot’s use.
According to news reports by CNBC and various other media outlets, the robot has seriously malfunctioned in a variety of ways during surgeries and is racking up a string of incident reports in the FDA’s “adverse event” database.
The types of malfunctions reported by the media and on the FDA database include:
- Instrument cable breaks that render the da Vinci robot non-functional and requires an instrument change
- The robot’s arm jumping, causing the instrument to stab an artery
- Damage to a patient’s ureter during a procedure
- The jaw on the EndoWrist instrument not articulating correctly, forcing surgeons to complete surgical procedures using open surgical techniques.
- The bipolar instrument firing unintentionally during a procedure, touching a patient’s uterus.
The robot has been tied to at least 70 deaths since 2009. The FDA is currently investigating the da Vinci robot and its problems. A recall of the device is reportedly being considered.