PROPERLY TRAINED TO USE THEM? OUR SENIOR INVESTIGATIVE
CORRESPONDENT CYNTHIA McFADDEN
HAS THAT STORY FOR US.
>> Reporter: THERE’S NO QUESTION
THAT THE DA VINCI SURGICAL ROBOT
SEEN HERE IN A MARKETING VIDEO
SUTURING A GRAPE WITH PRECISION
AND EASE CAN DO EXTRAORDINARY
THINGS.
THINGS. THE ONLY SURGICAL ROBOT OF ITS
KIND.
KIND. MANY DOCTORS, LIKE HEART SURGEON
DR. ROBERT POST SEEN HERE USING
THE DA VINCI, ARE BELIEVERS.
>> THE PATIENTS RECOVER QUICKER,
LESS BLOOD LOSS, LESS
COMPLICATIONS.
COMPLICATIONS. >> Reporter: THAT’S BECAUSE
THERE IS NO BIG INCISION.
ITS LAPAROSCOPIC SURGERY ON
STEROIDS.
STEROIDS. THE ROBOT CONTROLS THE
INSTRUMENTS GUIDED BY THE DOCTOR
AT A CONSOLE.
>> MY ABILITY TO BE PRECISE IS
BETTER, EVEN THAN MY OWN HANDS.
>> Reporter: BUT THE DA VINCI IS
NOT WITHOUT PROBLEMS.
IN THE LAST TEN YEARS, THERE
WERE 22,000 ADVERSE EVENTS FILED
IN AN FDA DATABASE WITH A RANGE
OF ISSUES ASSOCIATED WITH THE DA
VINCI, FROM THE MOST MINOR
MALFUNCTIONS TO 274 DEATHS.
LORI FEATHER STONE WHO LIVES
WITH HER DAUGHTER IN ALTUNA,
IOWA, WISHES SHE’D ASKED MORE
QUESTIONS BEFORE HAVING SURGERY
WITH THE ROBOTIC.
>>> AS YOU SIT HERE, ARE YOU
HAVING PAIN?
HAVING PAIN? >> YES.
>> YES. >> Reporter: ALL DIFFICULT EVERY
DAY?
DAY? >> SORRY.
>> SORRY. >> Reporter: THREE YEARS AGO HER
DOCTOR TOLD HER SHE NEEDED A
HYSTERECTOMY.
HYSTERECTOMY. >> SHE SAID SHE WOULD ELECT TO
HAVE THE ROBOT, LESS DOWN TIME,
LESS SCARRING.
LESS SCARRING. >> Reporter: BUT LORI HAD
SERIOUS COMPLICATIONS.
SERIOUS COMPLICATIONS. >> BASICALLY MY KIDNEYS WERE
DROWNING.
DROWNING. MY URETER HAD SOME TYPE OF
THERMAL INJURY.
THERMAL INJURY. >> Reporter: SO SOMEWHERE IN THE
COURSE OF THE SURGERY, YOU WERE
BURNED.
BURNED. >> UH-HUH.
>> UH-HUH. >> Reporter: HER DOCTORS’
POSTOPERATIVE REPORT CONFIRMS
THAT, ALSO NOTING HER COLON WAS
DAMAGED.
DAMAGED. SHE IS NOW FACING A PERMANENT
COLOSTOMY.
COLOSTOMY. ALL THIS A AFTER TWO YEARS OF DA
VINCI’S MANUFACTURER INTUITIVE
SURGICAL HAD BEEN PUT ON NOTICE
IN A STRONGLY WORDED LETTER FROM
THE FDA THAT, AMONG OTHER
THINGS, BURNING WAS A PROBLEM.
SADLY, LORI IS NOT ALONE.
NBC NEWS HAS SPOKEN TO MORE THAN
A DOZEN PATIENTS, MANY OF WHOM
ARE SUING, WHO SAY THEY WERE
BURNED OR OTHERWISE INJURED
DURING SURGERY WITH THE DA
VINCI.
VINCI. SOMETHING WE SAW REPORTED OVER
AND OVER AGAIN IN FDA DOCUMENTS.
SURGEON OBSERVED A FLAME, BURN
INJURY TO SMALL BOWEL, A BURN
INJURY TO LIVER.
DR. POSTIN HAS PER FORMED 1200
SURGERIES USING THE DA VINCI, HE
TELLS US BEFORE DOING HIS FIRST,
HE HAD ONLY TWO HOURS OF
PRACTICE ON THE DEVICE.
AND IS EXTREMELY WORRIED ABOUT
THE LACK OF DOCTOR TRAINING.
>> IF YOU WANT TO FLY A
COMMERCIAL AIRPLANE, IT TAKES
YOU 1500 HOURS.
YOU CAN FLY A ROBOT AFTER
TRAINING, WHICH ISN’T REALLY
THAT RIGOROUS.
THAT RIGOROUS. >> Reporter: IN FACT, THERE ARE
NO NATIONAL REQUIREMENTS
REGULATING HOW MUCH TRAINING A
SURGEON MUST HAVE TO OPERATE
USING THE DA VINCI.
THE FDA SAYS IT DOESN’T HAVE
JURISDICTION.
JURISDICTION. AND WHILE INTUITIVE SURGICAL
OFFERS A FOUR-LEVEL TRAINING
PROGRAM, IT CANNOT REQUIRE
SURGEONS TO COMPLETE IT.
>> THE ROOT CAUSE HERE IS THE
TRAINING.
TRAINING. THE WILLINGNESS TO SELL ROBOTS
TO PEOPLE AND PROMOTE THEM DOING
SURGERIES WHEN THEY WEREN’T
ADEQUATELY TRAINED.
ADEQUATELY TRAINED. THE WILLINGNESS OF HOSPITAL
CREDENTIALLING COMMITTEES TO
SIGN OFF ON THEM AND ALLOWING
THEM TO DO IT.
>> Reporter: DR. POSTIN HOPES
EVERY SURGEON WILL SEARCH HIS OR
HER OWN CONSCIENCE.
>> WE SHOULD LIVE IN A WORLD
WHERE WE PRACTICE BRUTAL
TRANSPARENCY WITH OUR PATIENTS.
SO, IF WE LIVED IN THAT WORLD,
WE WOULD TELL THE PATIENT, I’D
LIKE TO OPERATE ON YOU, BUT I
DIDN’T HAVE THE TIME OR MONEY TO
HAVE ALL THE TRAINING THAT I
REALLY THINK THAT WE OUGHT TO
HAVE HAD.
HAVE HAD. IS THAT OKAY?
IS THAT OKAY, WOULD YOU BE OKAY
WITH THAT?
WITH THAT? >> Reporter: THE ROBOT’S
MANUFACTURER TELLS NBC NEWS THAT
THEY, QUOTE, OFFER A
COMPREHENSIVE INTENSIVE TRAINING
PROGRAM THAT DEPENDS ON THE
SURGEON’S CAPABILITIES, AND THAT
THEY ALSO STRONGLY RECOMMEND
THAT SURGEONS CONTINUE TRAINING
THROUGHOUT THEIR CAREERS.
NOW, LORI FEATHERSTONE FILED
SUIT AGAINST INTUITIVE, BUT