ROBOTS in surgery ; ....The da Vinci is used for operations that include removing prostates, gallbladders and wombs, repairing heart valves, shrinking stomachs and transplanting organs. Its use has grown worldwide, but the system is most popular in the United States.
“We are at the tip of the iceberg. What we thought was impossible 10 years ago is now commonplace,” said Dr. Michael Stifelman, robotic surgery chief at New York University’s Langone Medical Center.
For surgeons, who control the robot while sitting at a computer screen, these operations can be less tiring. Plus robot hands don’t shake. Advocates say patients sometimes have less bleeding and often are sent home sooner than with conventional laparoscopic surgeries and operations involving large incisions.
But the Food and Drug Administration is looking into a spike in reported problems. Earlier this year, the FDA began surveying surgeons using the robotic system. The agency conducts such surveys of device use routinely, but FDA spokeswoman Synim Rivers said the reason for it now “is the increase in number of reports received” about da Vinci.
Reports filed since early last year include at least five deaths.
Whether there truly are more problems lately is uncertain. Rivers said she couldn’t quantify the increase and that it may simply reflect more awareness among doctors and hospitals. Doctors aren’t required to report such things; device makers and hospitals are.
It could also reflect wider use. Last year there were 367,000 robot-assisted surgeries versus 114,000 in 2008, according to da Vinci’s maker, Intuitive Surgical Inc. of Sunnyvale, Calif.
Da Vinci is the company’s only product, and it’s the only robotic system cleared for soft-tissue surgery by the FDA. Other robotic devices are approved for neurosurgery and orthopedics, among other things.
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. ... cont/-
ROBOTS in surgery ; ....The da Vinci is used for operations that include removing prostates, gallbladders and wombs, repairing heart valves, shrinking stomachs and transplanting organs. Its use has grown worldwide, but the system is most popular in the United States.
“We are at the tip of the iceberg. What we thought was impossible 10 years ago is now commonplace,” said Dr. Michael Stifelman, robotic surgery chief at New York University’s Langone Medical Center.
For surgeons, who control the robot while sitting at a computer screen, these operations can be less tiring. Plus robot hands don’t shake. Advocates say patients sometimes have less bleeding and often are sent home sooner than with conventional laparoscopic surgeries and operations involving large incisions.
But the Food and Drug Administration is looking into a spike in reported problems. Earlier this year, the FDA began surveying surgeons using the robotic system. The agency conducts such surveys of device use routinely, but FDA spokeswoman Synim Rivers said the reason for it now “is the increase in number of reports received” about da Vinci.
Reports filed since early last year include at least five deaths.
Whether there truly are more problems lately is uncertain. Rivers said she couldn’t quantify the increase and that it may simply reflect more awareness among doctors and hospitals. Doctors aren’t required to report such things; device makers and hospitals are.
It could also reflect wider use. Last year there were 367,000 robot-assisted surgeries versus 114,000 in 2008, according to da Vinci’s maker, Intuitive Surgical Inc. of Sunnyvale, Calif.
Da Vinci is the company’s only product, and it’s the only robotic system cleared for soft-tissue surgery by the FDA. Other robotic devices are approved for neurosurgery and orthopedics, among other things.
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. ... cont/- Robot wows surgeons, but freak episodes include robot hand that won’t let go, arm that hits http://wapo.st/Z55jOM via @washingtonpost
ROBOTS in surgery ; ....The da Vinci is used for operations that include removing prostates, gallbladders and wombs, repairing heart valves, shrinking stomachs and transplanting organs. Its use has grown worldwide, but the system is most popular in the United States.
ReplyDelete“We are at the tip of the iceberg. What we thought was impossible 10 years ago is now commonplace,” said Dr. Michael Stifelman, robotic surgery chief at New York University’s Langone Medical Center.
For surgeons, who control the robot while sitting at a computer screen, these operations can be less tiring. Plus robot hands don’t shake. Advocates say patients sometimes have less bleeding and often are sent home sooner than with conventional laparoscopic surgeries and operations involving large incisions.
But the Food and Drug Administration is looking into a spike in reported problems. Earlier this year, the FDA began surveying surgeons using the robotic system. The agency conducts such surveys of device use routinely, but FDA spokeswoman Synim Rivers said the reason for it now “is the increase in number of reports received” about da Vinci.
Reports filed since early last year include at least five deaths.
Whether there truly are more problems lately is uncertain. Rivers said she couldn’t quantify the increase and that it may simply reflect more awareness among doctors and hospitals. Doctors aren’t required to report such things; device makers and hospitals are.
It could also reflect wider use. Last year there were 367,000 robot-assisted surgeries versus 114,000 in 2008, according to da Vinci’s maker, Intuitive Surgical Inc. of Sunnyvale, Calif.
Da Vinci is the company’s only product, and it’s the only robotic system cleared for soft-tissue surgery by the FDA. Other robotic devices are approved for neurosurgery and orthopedics, among other things.
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.
... cont/-
ROBOTS in surgery ; ....The da Vinci is used for operations that include removing prostates, gallbladders and wombs, repairing heart valves, shrinking stomachs and transplanting organs. Its use has grown worldwide, but the system is most popular in the United States.
ReplyDelete“We are at the tip of the iceberg. What we thought was impossible 10 years ago is now commonplace,” said Dr. Michael Stifelman, robotic surgery chief at New York University’s Langone Medical Center.
For surgeons, who control the robot while sitting at a computer screen, these operations can be less tiring. Plus robot hands don’t shake. Advocates say patients sometimes have less bleeding and often are sent home sooner than with conventional laparoscopic surgeries and operations involving large incisions.
But the Food and Drug Administration is looking into a spike in reported problems. Earlier this year, the FDA began surveying surgeons using the robotic system. The agency conducts such surveys of device use routinely, but FDA spokeswoman Synim Rivers said the reason for it now “is the increase in number of reports received” about da Vinci.
Reports filed since early last year include at least five deaths.
Whether there truly are more problems lately is uncertain. Rivers said she couldn’t quantify the increase and that it may simply reflect more awareness among doctors and hospitals. Doctors aren’t required to report such things; device makers and hospitals are.
It could also reflect wider use. Last year there were 367,000 robot-assisted surgeries versus 114,000 in 2008, according to da Vinci’s maker, Intuitive Surgical Inc. of Sunnyvale, Calif.
Da Vinci is the company’s only product, and it’s the only robotic system cleared for soft-tissue surgery by the FDA. Other robotic devices are approved for neurosurgery and orthopedics, among other things.
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.
... cont/- Robot wows surgeons, but freak episodes include robot hand that won’t let go, arm that hits http://wapo.st/Z55jOM via @washingtonpost