DA VINCI SURGICAL SYSTEM
Report
- Report Number
- 2955842-2014-01955
- Event Type
- Injury
- Date Received
- April 3, 2014
- Report Date
- March 4, 2014
- Manufacturer
- INTUITIVE SURGICAL,INC.
- Product Code
- NAY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV
- Reporter Occupation
- OTHER
Narratives
IN RELATION TO THE REPORTED EVENT, ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: I HAD MY PROSTATE REMOVED VIA THE DA VINCI ROBOT. MY SURGEON SAID THAT THE DA VINCI ROBOT WAS THE DEVICE THAT WOULD DO A BETTER JOB, SAFER AND WITHOUT ANY COMPLICATIONS. MY SURGEON SAID THAT I WOULD ONLY HAVE TO BE IN THE HOSPITAL ONE NIGHT AND THAT HE WOULD BE ABLE TO SEE BETTER AND THAT USING THE DA VINCI ROBOT WOULD ALLOW HIM TO NOT CUT UNNECESSARY TISSUE, VEINS AND ETC. HE SAID THAT VIA USING THE DA VINCI ROBOT THAT I WOULD NOT HAVE INCONTINENCE OR HAVE ANY PROBLEM IN HAVING SEX. EVERYTHING THAT MY SURGEON SAID WAS FALSE. INSTEAD OF ONLY BEING IN THE HOSPITAL ONE NIGHT, I WAS IN THE HOSPITAL ALMOST A MONTH. DURING THAT MONTH IN THE HOSPITAL, I COULD NOT EAT, WALK, OR DO ANYTHING. I ALMOST BLED TO DEATH TWICE BECAUSE OF THE DAMAGE THAT THE DA VINCI ROBOT DID TO MY INSIDES. I HAVE HAD TO HAVE SIX MORE OPERATIONS AS A DIRECT RESULT OF MY SURGEON USING THE DA VINCI ROBOT ON ME. I WAS TOLD BY ONE OF HIS INTERNS THAT THE SURGEON LOST CONTROL OF THE DA VINCI ROBOT TWICE DURING MY OPERATION AND ONE TIME WHEN MY SURGEON WAS TRYING TO REMOVE ONE OF THE ARMS FROM MY BODY THAT THE DA VINCI ROBOT STARTED UP BY ITSELF AND DID DO ADDITIONAL INJURY TO MY BODY. ALSO, AS A DIRECT RESULT OF ALMOST DYING TWICE, BEING IN THE HOSPITAL FOR ALMOST A MONTH HAS CAUSED ME TO DEVELOP SEVERE ANXIETY ATTACKS AND DEEP DEPRESSION TO WHERE I HAVE TO SEE A PSYCHIATRIST EVERY THREE MONTHS AND A THERAPIST EVERY MONTH. I ALSO WILL HAVE TO TAKE PSYCH MEDICATIONS FOR THE REST OF MY LIFE (XANAX AND EFFEXOR XR). THE DA VINCI ROBOT HAS LEFT ME WITH NO QUALITY OF LIFE, IN FACT HAVING THE DA VINCI ROBOTIC OPERATION ALMOST CAUSED ME TO DIE TWICE AND HAS FOREVER CHANGED MY LIFE IN A NEGATIVE WAY. THE DA VINCI ROBOT SHOULD BE TAKEN OFF THE MARKET, SO THAT OTHER PTS CANNOT EXPERIENCE THE BAD THINGS THAT HAPPENED TO ME, BY HAVING SURGERY WITH THE DA VINCI ROBOT.
BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND THE CUSTOMER REPORTED FAILURE MODE. THE NAME OF THE HOSPITAL, DATE OF THE DA VINCI SURGICAL PROCEDURE, AND NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE ARE UNKNOWN. ISI HAS ATTEMPTED TO CONTACT THE PATIENT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT INDICATED THAT HE SUSTAINED INTRA-OPERATIVE COMPLICATIONS WHILE UNDERGOING A DA VINCI PROSTATECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLICATIONS IS UNKNOWN. IT IS ALSO UNKNOWN IF A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.
ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: I WAS OPERATED ON VIA THE USE OF A DA VINCI ROBOT IN (B)(6) 2008. INSTEAD OF BEING IN THE HOSPITAL ONLY ONE NIGHT, I STAY ALMOST A MONTH DUE TO COMPLICATIONS FROM BLEEDING. I HAVE HAD SIX ADD'L SURGERIES SINCE I HAD SURGERY VIA THE USE OF THE DA VINCI ROBOT. ONE OF THE INTERNS THAT WAS HELPING MY SURGEON TOLD ME THAT WHEN THE SURGEON TRIED TO REMOVE THE DA VINCI ROBOT FROM MY BODY THAT THE ROBOT STARTED BACK UP BY ITSELF AD DID CAUSE ADD'L DAMAGE TO MY INTERNAL ORGANS. I RECEIVED OVER 12 PINTS OF WHOLE BLOOD AND I ALMOST DIED TWICE DURING MY 30 DAY STAY IN THE HOSPITAL VIA THE DA VINCI ROBOTIC SURGERY. ALSO, AS A DIRECT RESULT OF ME ALMOST DYING TWICE AND BLEEDING TO DEATH HAS LEFT ME WITH SEVERE ANXIETY AND DEEP DEPRESSION TO THE EXTENT THAT I HAVE TO SEE A PSYCHIATRIST EVERY THREE MONTHS AND A THERAPIST EVERY MONTH. I HAVE TO TAKE PSYCH MEDICATIONS AND WILL DO SO FOR THE REST OF MY LIFE. ALSO, THE SURGEON TOLD ME THAT USING THE DA VINCI ROBOT WOULD DO A BETTER JOB AND THAT IT WOULD ALLOW HIM TO SEE BETTER AND THAT IT WOULD ALLOW HIM NOT TO CUT ANY UNNECESSARY VEINS OR BLOOD VESSELS AND THAT THE OPERATION WOULD NOT AFFECT MY SEXUAL FUNCTION. AS A DIRECT RESULT OF HAVING MY PROSTATE REMOVED VIA THE USE OF THE DA VINCI, I ALMOST DIED TWICE, IN THE HOSPITAL A MONTH, LOST 45 POUNDS, ALMOST BLED TO DEATH AND I HAVE HAD TO HAVE SIX ADD'L OPERATIONS TO CORRECT DAMAGES TO MY INTERNAL ORGANS. ALSO, THE WHOLE ORDEAL WITH THE DA VINCI ROBOT HAS CAUSED ME TO HAVE SEVERE ANXIETY AND DEEP DEPRESSION SO BAD THAT I WILL NEED TO TAKE PSYCH MEDS FOR THE REST OF MY LIFE, NOT INCLUDING ALWAYS BE IMPOTENT. I CANNOT BELIEVE THAT THE DA VINCI ROBOT WAS APPROVED BY THE FDA TO BE USED ON PATIENTS WITH ALL OF THE DEFECTS THAT IT HAS IN IT. I HAVE READ WHERE THERE HAS BEEN THOUSANDS OF PATIENTS THAT HAVE BEEN INJURED SEVERELY AND OTHERS HAVE DIED AS THE RESULT OF HAVING DA VINCI ROBOT SURGERY.
IN RELATION TO THE REPORTED EVENT, ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED VOLUNTARY REPORT MW5036521 WITH THE FOLLOWING EVENT DESCRIPTION: I HAD MY PROSTATE REMOVED VIA USE OF THE DA VINCI ROBOT TO REMOVE MY PROSTATE. WAS TOLD THAT THIS IS THE MOST MODERN WAY TO REMOVE THE PROSTATE AND THAT I WOULD ONLY BE IN THE HOSPITAL FOR ONE NIGHT. I WAS IN THE HOSPITAL FOR ONE NIGHT. I WAS IN THE HOSPITAL FOR A MONTH AND HAD TO HAVE NUMEROUS BLOOD TRANSFUSIONS AND I ALMOST DIED TWICE. I COULD NOT WALK, COULD NOT EAT, AND I LOST ABOUT THIRTY POUNDS. SINCE MY OPERATION WITH THE DA VINCI ROBOT SURGERY, I HAVE HAD 6 ADDITIONAL OPERATIONS FOR DAMAGES THAT WERE CAUSED BY THE DA VINCI ROBOT. I PERSONALLY FEEL THAT IF MY SURGEON HAD USED CONVENTIONAL SURGERY TECHNIQUES THAT I WOULD NOT HAVE HAD SIX ADDITIONAL OPERATIONS TO CORRECT PROBLEMS THAT THE DA VINCI ROBOT CAUSED TO MY BODY. ALSO, AS A DIRECT RESULT OF BEING IN THE HOSPITAL FOR A MONTH AND ALMOST DYING TWICE CAUSED ME TO HAVE PSYCHOLOGICAL PROBLEMS FOR WHICH I HAVE TO SEE A PSYCHIATRIST EVERY THREE MONTHS AND A THERAPIST EVERY MONTH AND I HAVE TO TAKE PSYCH MEDICATION FOR THE REST OF MY LIFE. I TAKE EFFEXOR XR 22MG ONCE A DAY AND XANAX 4 TIMES A DAY. I WOULD NOT HAVE HAD ANY MENTAL PROBLEM IF I WOULD HAVE HAD CONVENTIONAL SURGERY INSTEAD OF HAVING MY SURGERY WITH THE DA VINCI ROBOT WHICH ALMOST KILLED ME. I FEEL THAT THE MFR INTUITIVE SURGICAL COMPANY RUSHED TO MARKET AN UNSAFE SURGICAL DEVICE THAT HAD DEFECTS IN IT AND THAT INTUITIVE WAS MORE INTERESTED IN MAKING MONEY INSTEAD OF THE WELFARE OF THE PATIENTS. INTUITIVE'S GREED FOR MONEY OVERTOOK MY SAFETY ASPECTS OF THEIR PRODUCT. THE DA VINCI ROBOT. I FEEL THAT THE DA VINCI ROBOT SHOULD BE TAKEN OFF OF THE MARKET AND RECALLED UNTIL INTUITIVE HAS PROVEN THAT THEIR DA VINCI ROBOT IS DEFECT FREE AND DOES NOT INJURE PATIENTS LIKE ME. I ALSO THINK THAT THE FDA WAS TOO QUICK IN APPROVING THE USE OF THE DA VINCI ROBOT WITHOUT FIRST CONDUCTING A THOROUGH INVESTIGATION INTO ANY MALFUNCTIONS, DEFECTS, AND INJURIES THAT THE DA VINCI ROBOT MAY CAUSE TO THE PT. MY OPERATION WITH THE DA VINCI ROBOT HAS DESTROYED ANY QUALITY OF LIFE THAT I HAD AND THERE SHOULD BE SOME SORT OF ACTION TAKEN AGAINST INTUITIVE SURGICAL SUPPLY COMPANY FOR PUTTING A DEFECTIVE DEVICE ON THE MARKET THAT HAS KILLED, MAIMED AND DESTROYED PATIENT'S LIVES. ADVICE PLEASE.
IN RELATION TO THE REPORTED EVENT, ON 9/26/2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: I WAS OPERATED ON VIA THE USE OF THE DA VINCI ROBOT TO REMOVE MY PROSTATE. THE SURGEON DID NOT EXPLAIN TO ME OR MY FAMILY ANYTHING ABOUT THE DA VINCI ROBOT EXCEPT TO SAY THAT USING THE ROBOT WOULD ALLOW ME TO GO HOME THE NEXT DAY. I WAS IN THE HOSPITAL FOR A MONTH AND DURING THAT MONTH. I ALMOST DIED TWICE AND THE BLUE TEAM HAD TO BE CALLED TO RESUSCITATE ME OR I WOULD NOT BE ALIVE TO WRITE THIS LETTER. DURING MY STAY IN THE HOSPITAL, THE NURSES CAME TO EMPTY THE CONTENTS OF MY DRAINAGE BAG. THEY WOULD MEASURE THE AMOUNT OF FLUID AND THEN FLUSH THE FLUID DOWN THE COMMODE. WHAT THE NURSES WERE DOING WAS FLUSHING MY LIFE'S BLOOD DOWN THE COMMODE. I HAD TO HAVE MULTIPLE WHOLE BLOOD TRANSFUSIONS. I COULD NOT EAT, WALK, SHOWER AND I LOST ABOUT 40 POUNDS DURING MY STAY IN THE HOSPITAL. FINALLY I WAS RELEASED TO GO HOME AND WITHIN FOUR HOURS I HAD TO BE READMITTED WHERE I STAYED ANOTHER WEEK. THE ORDEAL OF ALMOST DYING TWICE AND STAYING IN THE HOSPITAL FOR OVER A MONTH, LEFT ME WITH DEEP DEPRESSION AND SEVERE ANXIETY ATTACKS WHERE I NOW HAVE TO SEE MY PSYCHIATRIST EVERY THREE MONTHS, AND MY THERAPIST EVERY MONTH. I HAVE TO PSYCH DRUGS FOR THE REST OF MY LIFE AND I NOW TAKE EFFEXOR XR 225 MG, AND XANAX 4 TIMES A DAY. I WAS TOLD BY AN INTERN THAT HELPED WITH MY SURGERY VIA THE USE OF THE DA VINCI ROBOT THAT WHEN THE SURGEON WAS TRYING TO REMOVE ONE OF THE ARMS FROM MY BODY THAT THE ROBOT STARTED BACK UP BY ITSELF AND DID ADDITIONAL DAMAGE TO MY INTERNAL ORGANS. THE SAME INTERN SAID THAT MY SURGEON TOLD HIM AND ANOTHER INTERN THAT HE DID NOT THINK THAT I WOULD LIVE LONG ENOUGH TO GET OUT OF THE HOSPITAL. THE SURGEON NEVER DID COME TO SEE ME OR CHECK ON ME HE ALWAYS SENT THE TOW INTERNS. SINCE MY SURGERY USING THE DA VINCI ROBOT, I HAVE HAD SIX MORE OPERATIONS THAT WERE A DIRECT RESULT OF INJURIES THAT WERE CAUSED BY THE DA VINCI ROBOT. I HAD TO HAVE TWO INCONTINENCE OPERATIONS, THREE HERNIA OPERATIONS AND A PENILE IMPLANT THAT DOES NOT WORK FOR ME. I FEEL THAT THE FDA SHOULD ISSUE A CEASE TO MANUFACTURE ORDER TO INTUITIVE SURGICAL, ALSO ORDER INTUITIVE TO RECALL ALL OF THEIR DA VINCI ROBOTS UNTIL THEY CAN PROVE THAT EVERY ROBOT IS FREE FROM DEFECTS. ALSO, THE FDA SHOULD ISSUE A WARNING AND CEASE ORDER TO ALL HOSPITAL THAT ARE PERFORMING OPERATIONS WITH THE DEFECTIVE DA VINCI ROBOTS.
ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: I HAD MY PROSTATE REMOVED THE DA VINCI ROBOT AND DURING MY SURGERY, MY SURGEON ATTEMPTED TO FUSE TOGETHER SOME BLOOD VESSELS AND THE ROBOT FAILED TO FUSE SOME OF MY BLOOD VESSELS TOGETHER THUS CAUSING ME TO BLEED INTERNALLY. INSTEAD OF BEING IN THE HOSPITAL ONE NIGHT, I WAS IN THE HOSPITAL FOR OVER THIRTY DAYS. ALSO, ONE OF MY SURGEON'S INTERNS TOLD ME THAT WHEN MY SURGEON WAS ATTEMPTING TO REMOVE THE ROBOT FROM MY BODY THAT THE ROBOT STARTED UP ON ITS OWN AND DID CUT OTHER BLOOD VEINS. NO WHERE IN MY MEDICAL RECORDS WAS ANY OF WHAT HAPPENED TO ME WAS IN THE MEDICAL RECORDS THAT I OBTAINED FROM THE HOSPITAL. THE HOSPITAL HAD TO GIVE ME OVER 8 PINTS OF BLOOD AND I HAD TO STAY IN THE HOSPITAL FOR OVER 30 DAYS. THE OPERATION USING THE DA VINCI ROBOT ALMOST CAUSED ME THE LOSS OF MY LIFE AND I AM NOW BEING TREATED FOR SEVERE ANXIETY AND DEPRESSION OVER WHAT HAPPENED TO ME WHILE I WAS OPERATED ON VIA DA VINCI ROBOT. NONE OF WHAT I HAVE SAID WAS REPORTED ON ANY MEDICAL RECORDS THAT I PAID TO GET. MY SURGEON AND THE HOSPITAL COVERED UP WHAT ACTUALLY HAPPENED TO ME WHEN I HAD MY DA VINCI SURGERY. I THOUGHT BY LAW THAT A SURGEON AND HOSPITAL WAS SUPPOSED TO REPORT ANYTHING GOOD OR BAD THAT HAPPENS TO A PT THAT IS HAVING AN OPERATION WHICH ENDS UP BADLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200996 | DA VINCI SURGICAL SYSTEM | ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | NAY | INTUITIVE SURGICAL,INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |