da Vinci robot allegedly failed with errors mid-surgery in Pennsylvania

What happened

On June 9, 2005, a man diagnosed with prostate cancer underwent a prostatectomy. His surgeon planned to operate with a da Vinci surgical robot. The patient later sued Bryn Mawr Hospital in Pennsylvania and the robot’s maker over the operation.

According to the facts as summarized by the U.S. Court of Appeals for the Third Circuit, the patient alleged that the robot malfunctioned during the operation and displayed error messages. The surgical team tried to get it working again and could not. A representative of the manufacturer came to the operating room and was also unable to make the robot functional. The surgeon completed the procedure using laparoscopic instruments instead.

A week later the patient had blood in his urine and was hospitalized. He said he subsequently suffered erectile dysfunction, which he had not had before the surgery, and severe groin pain. The court noted that the surgeon’s operative report described a malfunction of the robot but did not discuss its cause.

The system involved

The da Vinci is a surgeon-controlled robotic system made by Intuitive Surgical. The surgeon directs its instrument arms from a console; when the system cannot be used, an operation can be continued with hand-held laparoscopic tools or converted to open surgery.

The court record does not identify the model of the robot or the nature of the errors it displayed.

Investigation and response

The patient sued the hospital and Intuitive Surgical in state court on theories of strict product liability, malfunction liability, negligence and breach of warranty. The hospital was voluntarily dismissed and Intuitive moved the case to federal court.

On March 11, 2009, the district court granted summary judgment to Intuitive, holding that the patient had offered no evidence ruling out other causes of the malfunction or showing that it caused his injuries; he had not submitted any expert report. On January 28, 2010, the Third Circuit affirmed in a non-precedential opinion, stating that there was no evidence in the record from which a jury could infer that the erectile dysfunction and groin pain were caused by the alleged malfunction.

What is not established

What caused the robot to display errors, and whether the interruption contributed to the patient’s later symptoms, was never established. The courts did not rule on whether the robot was defective, only that the patient had not produced evidence linking a defect to his injuries. The appellate opinion names Bryn Mawr Hospital as a defendant but does not otherwise describe where the surgery took place.