La FDA mène une enquête sur les incidents des robots de chirurgie.
FDA Probing Spike in Robotic Surgery Problems - ABC News
The biggest thing in operating rooms these days is a million-dollar, multi-armed robot named da Vinci, used in nearly 400,000 surgeries nationwide last year — triple the number just four years earlier.
But now the high-tech helper is under scrutiny over reports of problems, including several deaths that may be linked with it, and the high cost of using the robotic system.
There also have been a few disturbing, freak incidents: a robotic hand that wouldn’t let go of tissue grasped during surgery and a robotic arm hitting a patient in the face as she lay on the operating table.
Les quelques incidents rapportés (sur presque 400 000 interventions en 2012 aux É.-U.) sont assez impressionnants…
A search for the company’s name in an FDA medical device database of reported problems brings up 500 events since Jan. 1, 2012. Many of those came from Intuitive Surgical. The reports include incidents that happened several years ago and some are duplicates. There’s also no proof any of the problems were caused by the robot, and many didn’t injure patients. Reports filed this year include:
— A woman who died during a 2012 hysterectomy when the surgeon-controlled robot accidentally nicked a blood vessel.
— A Chicago man who died in 2007 after spleen surgery.
— A New York man whose colon was allegedly perforated during prostate surgery. Da Vinci’s maker filed that report after seeing a newspaper article about it and said the doctor’s office declined to provide additional information.
— A robotic arm that wouldn’t let go of tissue grasped during colorectal surgery on Jan. 14. “We had to do a total system shutdown to get the grasper to open its jaws,” said the report filed by the hospital. The report said the patient was not injured.
— A robotic arm hit a patient in the face during a hysterectomy. Intuitive Surgical filed the report and said it’s not known if the patient was injured but that the surgeon decided to switch to an open, more invasive operation instead.
On constate, surtout, que la déclaration et l’analyse des incidents laissent fortement à désirer (sous-déclaration ? impact de l’incident ?)