{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "NO INFORMATION", "report_to_fda": "I", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "MW5064382", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20160824", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20130315", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PATIENT", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20160829", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "551218", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160824", "brand_name": "DA VINCI ROBOT", "generic_name": "DA VINCI ROBOT", "manufacturer_d_name": "INTUITIVE SURGICAL SUPPLY", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", 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"", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "0", "date_received": "20160824", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " O" ], "patient_age": "73 YR", "patient_sex": "", "patient_weight": "90", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "Fainting", "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Impotence", "Incontinence", "Nausea", "Pain", "Loss of Range of Motion", "Tissue Damage", "Perforation of Vessels", "Weakness", "Hernia", "Anxiety", "Depression", "Ambulation or Postural Difficulties", "Cardiac Arrest", "Fainting", "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Impotence", "Incontinence", "Nausea", "Pain", "Loss of Range of Motion", "Tissue Damage", "Perforation of Vessels", "Weakness", "Hernia", "Anxiety", "Depression", "Ambulation or Postural Difficulties" ] }, { "patient_sequence_number": "1", "date_received": "20160824", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " O" ], "patient_age": "73 YR", "patient_sex": "", "patient_weight": "90", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Pain", "Loss of Range of Motion", "Weakness", "Ambulation or Postural Difficulties", "Cardiac Arrest", "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Pain", "Loss of Range of Motion", "Weakness", "Ambulation or Postural Difficulties" ] } ], "distributor_city": "", "date_report": "20160824", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5910124", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "53467949", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "(B)(6) RE: DA VINCI ROBOT IS A VERY DANGEROUS OPERATION DEVICE. DEAR SIR: I AM WRITING A LETTER TO YOU EXPLAINING JUST WHAT HAPPENED TO ME WHEN I WAS OPERATED ON VIA DA-VINCI ROBOT. FIRST OF ALL, MY UROLOGIST/SURGEON (MR. (B)(6)) TOLD ME AND MY FAMILY THAT I HAD DEVELOPED PROSTATE CANCER AND THAT I WOULD HAVE TO HAVE MY PROSTATE REMOVED. ON THE GLEASON SCALE READING OF 6, DR. (B)(6) SAID THAT HE RECOMMENDED USING THE DA-VINCI ROBOT BECAUSE IT WOULD DO A BETTER JOB AND THAT IT WOULD ALLOW HIM TO SEE EVERYTHING ON A BIG SCREEN SO THAT HE WOULD BE ABLE NOT TO CUT ANY NERVES OR BLOOD VESSELS THAT WOULD AFFECT ME FROM HAVING SEX AND THAT IT WOULD PREVENT ME FROM HAVING INCONTINENCE. DR. (B)(6) CONVINCED ME AND MY FAMILY THAT THE DA-VINCI ROBOT WAS THE WAY TO GO AND THAT MY FAMILY COULD PICK ME UP AT THE HOSPITAL THE NEXT MORNING. WHEN MY FAMILY CAME TO GET ME, I WAS IN A BAD WAY. I COULD NOT STAND, EAT, MOVE AND I WAS IN SO MUCH PAIN. THE NURSES HAD PUT ON ME A DRAINAGE BAG AND ABOUT EVERY TWO HOURS THE BAG WOULD FILL UP WITH BRIGHT RED BLOOD JUST LIKE IF I HAD JUST CUT MYSELF. DRAINAGE WOULD NOT BE THE SAME COLOR AS PURE BLOOD. DR. (B)(6) TOLD MY FAMILY THAT I WOULD NOT BE GOING HOME BECAUSE OF COMPLICATIONS DURING SURGERY. DR. (B)(6) SAID THAT IT HAPPENS SOMETIMES DURING ROBOTIC SURGERY. MY HOSPITAL RECORDS SHOWS THAT DURING THE FIRST WEEK IN THE HOSPITAL THE NURSES HAD GIVEN ME THREE PINTS OF WHOLE BLOOD AND TWO WEEKS LATER, THE NURSES HAD TO GIVE 3 MORE PINTS OF WHOLE BLOOD. I BECAME WEAKER AND WEAKER. I COULD NOT WALK AND I COULD NOT EAT AND I WAS MISERABLE. INSTEAD OF BEING IN THE HOSPITAL FOR ONE NIGHT, I ENDED UP BEING IN THE HOSPITAL FROM (B)(6) 2009, ALMOST A MONTH. I WAS SLOWLY BLEEDING TO DEATH INTERNALLY AND NO ONE AT THE (B)(6) (MEMORIAL) HOSPITAL HAD CAUGHT THE FACT THAT I WAS FILLING UP THE SO-CALLED DRAINAGE POUCH EVERY TWO HOURS WITH MY LIFE'S BLOOD. I WAS BLEEDING INTERNALLY AND NO ONE CAUGHT IT. ONE NIGHT ABOUT 2:00 AM MY COUSIN WAS IN MY ROOM WITH ME AND I LOOKED AT HIM AND I TOLD HIM THAT I LOVED HIM AND FOR HIM TO TELL MY FAMILY THAT I LOVED THEM. I TOLD HIM THAT I WAS DYING BECAUSE THE ROOM WAS BECOMING DARKER AND DARKER. HE TOOK OFF RUNNING TO GET A NURSE. THE NURSE CHECKED MY BLOOD PRESSURE AND IT WAS 42/36. THE NURSE IMMEDIATELY CALLED THE BLUE RESCUE TEAM TO RESITUATE ME. THE BLUE TEAM WORKED ON ME FOR OVER AN HOUR AND THEY ENDED UP GIVING ME 5 PINTS OF WHOLE BLOOD. ALL OF THE BLOOD THAT WAS IN THE DRAINAGE BAG WAS MY LIFE'S BLOOD AND THE NURSES WOULD SIMPLY WRITE DOWN HOW MUCH FLUID WAS IN THE DRAINAGE BAG AND THEN POURED THE CONTENTS DOWN THE COMMODE. THE NURSES WERE LITERALLY POURING MY LIFE'S BLOOD DOWN THE TOILET. THERE WERE TWO INTERNS THAT HELPED DR. (B)(6) WITH THE DA-VINCI ROBOTIC SURGERY ON THE REMOVAL OF MY PROSTATE. LAST YEAR I SAW ONE OF THE INTERNS THAT HAD ASSISTED WITH MY DA-VINCI SURGERY AND HIS NAME IS DR. (B)(6), AND HE HAS HIS OWN UROLOGY PRACTICE NOW. DR. (B)(6) AND I TALKED ABOUT WHAT HAD GONE WRONG DURING MY PROSTATE SURGERY USING THE DA-VINCI ROBOT. DR. (B)(6) SAID THAT DR. (B)(6) (THE DA-VINCI ROBOT SURGEON) SAID THAT HE THOUGHT THAT THEY WERE GOING TO LOSE MR.(B)(6) BECAUSE OF INTERNAL BLEEDING. DR. (B)(6) NEVER CAME TO SEE ME AFTER MY ROBOTIC SURGERY AND HE NEVER TOLD ME OR MY FAMILY WHAT WENT WRONG. ONLY HIS INTERNS CAME TO SEE ME AND THEY NEVER SAID ANYTHING ABOUT WHAT HAD GONE WRONG DURING MY ROBOTIC SURGERY. DR. (B)(6) DID NOTHING TO RECTIFY MY INTERNAL BLEEDING. DR. (B)(6) SAID THAT HE COULD TELL ME A LOT MORE, BUT HE WAS AFRAID THAT DR. (B)(6) WOULD SUE HIM. I AM NOT CERTAIN THAT DR. (B)(6) IS CERTIFIED TO PERFORM ROBOTIC SURGERY OR NOT. THE WAY THAT MY SURGERY WAS BUNGLED, MAKES ME FEEL THAT HE IS NOT QUALIFIED TO PERFORM DA-VINCI." }, { "mdr_text_key": "241269434", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ADD'L INFO RECEIVED FROM REPORTER ON (B)(6) 2016 FOR MW5064382: I AM NOT CERTAIN THAT DR. (B)(6) IS CERTIFIED TO PERFORM ROBOTIC SURGERY OR NOT. THE WAY THAT MY SURGERY WAS BUNGLED, MAKES ME FEEL THAT HE IS NOT QUALIFIED TO PERFORM DA VINCI ROBOTIC SURGERY. I GUESS AFTER HE HAD PERFORMED THE SURGERY AND HE KNEW THAT THINGS WENT BAD FOR ME, I NEVER SAW DR. (B)(6) AGAIN WHILE I WAS IN THE HOSPITAL FOR ALMOST A MONTH. I SAW THE INTERNS. DR. (B)(6). DR SAID THAT DR. (B)(6) THOUGHT THAT HE HAD FUSED SOME BLOOD VESSELS TOGETHER AND HE THOUGHT THAT THEY WERE FUSED TOGETHER BUT IN FACT THEY WERE NOT FUSED TOGETHER. BECAUSE THE BLOOD VESSELS WERE NOT FUSED TOGETHER CAUSED ME TO LOSE MORE THAN 12 PINTS OF WHOLE BLOOD FROM (B)(6) 2008 , AND I HAD TO BE RE-ADMITTED AND I HAD TO STAY TWO MORE WEEKS. DR. (B)(6) ALSO SAID THAT DR. (B)(6) SEEMED TO LOSE CONTROL OF THE DA VINCI ROBOT WHEN HE TRIED TO REMOVE IT FROM MY BODY. AFTER THREE WEEKS IN THE HOSPITAL, I WAS ALLOWED TO GO HOME, HOWEVER, I HAD TO BE RE-ADMITTED THE NEXT DAY BECAUSE I WAS FAINTING, NAUSEATED, COULD NOT EAT AND I WAS HURTING BADLY. I WAS READMITTED TO THE HOSPITAL AND I REMAINED IN THE HOSPITAL ANOTHER WEEK, I STARTED FEELING BETTER AND THERE WAS NOT VERY MUCH DRAINAGE OR BLOOD IN MY DRAINAGE BAG. I WANT YOU TO KNOW THAT I ALMOST LOST MY LIFE BY HAVING DA VINCI ROBOTIC SURGERY TO REMOVE MY PROSTATE. DR. (B)(6) HAD SAID THAT USING THE DA VINCI ROBOT WOULD ALLOW HIM TO SEE BETTER AND THAT HE WOULD BE ABLE NOT TO CUT ANY BLOOD VESSELS OR CONNECTING TISSUE THAT WOULD KEEP ME FROM HAVING ERECTIONS OR INCONTINENCE. EVERYTHING THAT DR. (B)(6) SAID WAS A COMPLETE LIE BECAUSE I ENDED UP IN THE HOSPITAL ABOUT 30 DAYS INSTEAD OF ONLY ONE NIGHT. I ALSO ALMOST BLED TO DEATH, BECAUSE DR. (B)(6) AND THE NURSES DID NOT KNOW THE DIFFERENCE BETWEEN WHOLE BLOOD AND DRAINAGE. IF MY COUSIN HAD NOT BEEN PRESENT AT 2:00 A.M. THEN I WOULD HAVE DIED BECAUSE I HAD LOST THREE PINTS OF BLOOD DURING THE FIRST WEEK AFTER MY ROBOTIC SURGERY AND THEN TWO WEEKS LATER THE NURSES HAD TO GIVE ME FIVE MORE PINTS OF WHOLE BLOOD. DR. (B)(6) (DR. (B)(6) 'S INTERNS) TOLD ME IN THE HOSPITAL THAT THEY HAD ASSISTED WITH MY OPERATION AND SAID THAT DR. (B)(6) SEEMED TO HAVE LOST CONTROL OF THE DA-VINCI ROBOT WHEN HE TRIED TO REMOVE IT FROM MY BODY AND THAT CAUSED THE DA-VINCI ROBOT TO CUT BLOOD VESSELS, SURROUNDING TISSUE AND OTHER ORGANS. AFTER I WAS ABLE TO GO HOME I HAD INCONTINENCE REALLY BAD. URINE WOULD CONSTANTLY DRIP FROM MY PENIS AND DR. (B)(6) SAID THAT HE KNEW A DOCTOR IN (B)(6) THAT HAS A NEW PROCEDURE THAT WOULD STOP MY INCONTINENCE. I AGREED TO HAVE THE INCONTINENCE OPERATION WHICH ENTAILED USING MESH TO RAISE MY BLADDER TO A HIGHER LEVEL AND THAT WAS SUPPOSED TO STOP MY INCONTINENCE. THIS OPERATION WAS A TOTAL FAILURE. I STILL CONTINUED TO HAVE INCONTINENCE PROBLEMS JUST LIKE I HAD BEFORE THE INCONTINENCE OPERATION. SHORTLY AFTER I HAD THE PROSTATE SURGERY USING THE DA-VINCI ROBOT MY FAMILY DOCTOR, DR. B)(6) TOLD ME THAT I HAD TWO HERNIAS, ONE ON THE RIGHT SIDE AND ONE ON THE LEFT SIDE. I DID NOT HAVE ANY HERNIAS BEFORE I HAD THE DA VINCI ROBOTIC SURGERY TO REMOVE MY PROSTATE AND AFTER I HAD THE INCONTINENCE OPERATION TO SUPPOSEDLY FIX MY INCONTINENCE PROBLEM. I THINK THAT LOSING CONTROL OF THE DA-VINCI ROBOT WHEN DR. (B)(6) WAS TRYING TO REMOVE THE DA-VINCI ROBOT FROM MY BODY AND THE ROBOT STARTED BACK UP VIA ITSELF DID CUT THE TISSUE BETWEEN MY STOMACH AND INTESTINES THUS CAUSING ME TO HAVE DOUBLE HERNIAS. I HAVE BECOME COMPLETELY IMPOTENT AND THE SURGEON THAT PERFORMED MY DA VINCI ROBOTIC SURGERY TO REMOVE MY PROSTATE (DR. B)(6) ) SAID THAT BY USING THE DA VINCI ROBOT WOULD ALLOW HIM TO SEE BETTER AND ALLOW HIM TO DO A BETTER JOB AND THAT IT WOULD NOT CAUSE ME TO BE IMPOTENT. DR. ((B)(6) REFERRED ME TO ANOTHER UROLOGIST (DR. (B)(6) ) IN (B)(6) 2010 I HAD AN APPOINTMENT WITH DR. (B)(6) AND HE SAID THAT HE COULD FIX MY INCONTINENCE PROBLEM BY INSERTING A NEW INCONTINENCE DEVICE INSIDE OF ME AND ALL THAT I HAVE TO DO IS TO PUSH A BUTTON AND THE ARTIFICIAL DEVICE WOULD ALLOW ME TO URINATE AS NORMAL AND AFTER 70 SECONDS THE DEVICE STARTS TO CLOSE AUTOMATICALLY AND THERE IS NO INCONTINENCE. I TOLD DR. (B)(6) THAT I WOULD GET BACK TO HIM AT A LATER DATE BECAUSE I HAD TO HAVE TWO HERNIAS OPERATIONS BEFORE I WOULD CONSIDER THE INCONTINENCE DEVICE OPERATION. I HAD ONE HERNIA (SUPPOSEDLY REPAIRED ON THE RIGHT SIDE) BY DOCTOR (B)(6) . WHEN I WENT BACK TO MY FAMILY PHYSICIAN (DR. (B)(6) ) HE CHECKED MY RIGHT SIDE WHERE I HAD HERNIA SURGERY. DR. (B)(6) SAID THAT HE THOUGHT THAT I SAID THAT I HAD MY RIGHT SIDE HERNIA FIXED. DR. (B)(6) SAID THAT MY RIGHT HERNIA WAS STILL THERE. I THEN WENT TO ANOTHER DOCTOR (DR. (B)(6) ) I HAD THE TWO HERNIAS OPERATED PERFORMED BY DR. (B)(6) AND AFTER I RECOVERED FROM HERNIA SURGERY I HAD THE INCONTINENCE DEVICE IMPLANTED IN ME BY DR (B)(6). THE INCONTINENCE DEVICE WORKS FINE AND YOU WOULD NEVER KNOW THAT I EVER HAD INCONTINENCE. ALSO, DR. ((B)(6) SAID THAT THERE ARE NEW DEVICES ON THE MARKET THAT \"WOULD ALLOW ME TO RESUME HAVING SEX IF I WAS INTERESTED. I TOLD HIM THAT I WAS VERY INTERESTED IN THIS LATEST PENILE IMPLANT AND DR. (B)(6) OPERATED ON ME ON (B)(6) 2013, AND BECAUSE SO MUCH DAMAGE WAS CAUSED TO ME BY THE USE OF THE DA VINCI ROBOT SURGERY THAT THE PENILE IMPLANT DOES NOT WORK FOR ME. I HAVE LOST THE ABILITY TO EVER HAVE SEX FOR THE REST OF MY LIFE. ALSO, I HAVE HAD THREE HERNIA OPERATIONS (ONE BY DR. (B)(6) AND TWO BY DR. (B)(6)) REPAIRED. I ASKED DR. (B)(6) IF HE THOUGHT THAT BY HAVING MY PROSTATE REMOVED BY THE USE OF THE DA-VINCI ROBOT AND THE SURGEON LOST CONTROL OF THE DA-VINCI ROBOT, IF THE DA-VINCI ROBOT COULD HAVE CUT MY INTESTINES AND CAUSED MY INTERNAL BLEEDING AND MY DOUBLE HERNIA'S, HIS ANSWER WAS IT IS COMPLETELY POSSIBLE BECAUSE I DID NOT HAVE ANY HERNIAS UNTIL AFTER I HAD THE DA-VINCI ROBOTIC SURGERY TO REMOVE MY PROSTATE. IN ALL, I HAD FOUR HERNIA OPERATIONS, TWO INCONTINENCE OPERATIONS AND A PENILE IMPLANT OPERATION THAT DOES NOT WORK BECAUSE OF THE DAMAGES THAT THE DA VINCI ROBOT CAUSED DURING MY PROSTATE SURGERY. HAVING THE DA VINCI ROBOTIC SURGERY HAS CAUSED ME TO HAVE 7 MORE OPERATIONS BECAUSE OF THE DEFECTS THAT WERE IN THE DA VINCI ROBOT ITSELF . INTUITIVE SURGICAL SUPPLIES IS THE MANUFACTURER OF THE DA VINCI ROBOT SURGICAL DEVICE THAT IS USED TO PERFORM SURGERIES OF VARIOUS TYPES ON A GREAT NUMBER OF PEOPLE AND IT DOES HAVE DEFECTS AND FLAWS IN IT THAT CAUSES PEOPLE TO DIE, HAVE EXCESS BLEEDING, CUTS, NICKS OTHER TISSUES AND BLOOD VEINS AND DAMAGES OTHER ORGANS AND IS NOT 100% CONTROLLABLE BY THE SURGEON THAT USES THE DA VINCI ROBOT. JUST ABOUT EVERY DAY I HEAR ON THE NEWS OR READ IN THE NEWSPAPERS WHERE SOMEONE WHO HAS SURGERY VIA THE USE OF THE DA VINCI ROBOT HAS BEEN INJURED, EITHER BURNED, EXCESS BLEEDING, OTHER INTERNAL INJURIES AND EVEN HAS CAUSED DEATH TO PATIENTS TO THE EXTENT THAT THE FEDERAL DRUG ADMINISTRATION HAS ISSUED A RECALL ON DA VINCI ROBOTS FOR CAUSING EXTENSIVE DAMAGES TO PATIENTS THAT THE DEVICE IS USED ON. I SAW LAST WEEK ON TELEVISION NEWS WHERE THE FDA IS GOING TO RECALL AND INVESTIGATE THE MANUFACTURERS OF THE DA VINCI ROBOTS (INTUITIVE SURGICAL INC.) FOR MANUFACTURING A DEFECTIVE SURGICAL DEVICE (DA VINCI ROBOT) THAT HAS MECHANICAL DEFECTS IN IT THAT DO MORE HARM THAN GOOD. EVER SINCE I HAD MY PROSTATE REMOVED VIA THE USE OF THE DA VINCI ROBOT, I DO NOT HAVE ANY QUALITY OF LIFE ANYMORE. ALSO, THE TRAUMA OF ALMOST DYING TWICE, BLEEDING TO DEATH SEVERAL TIMES AND BEING A PATIENT IN THE HOSPITAL FOR ALMOST A MONTH HAS CAUSED ME TO SUFFER SEVERE ANXIETY ATTACKS AND DEEP DEPRESSION. AFTER MY ORDEAL WITH THE DA VINCI ROBOT, I NOW HAVE TO SEE A PSYCHIATRIST EVERY THREE MONTHS AND TAKE PSYCH. MEDICATIONS. XANAX FOUR TIMES A DAY AND EFFEXOR XR ONCE A DAY. I WILL HAVE TO DO THIS FOR THE REST OF MY LIFE. THE DA VINCI ROBOT OPERATION DESTROYED ANY QUALITY OF LIFE THAT I HAD. IN ESSENCE, SINCE I HAD THE DA VINCI ROBOTIC SURGERY, I HAVE HAD TO HAVE 6 MORE OPERATIONS. IF THE DA VINCI ROBOT IS CAUSING MORE INJURIES AND DEATHS THAN TRADITIONAL SURGERIES THEN THE DA VINCI ROBOT SHOULD BE BANNED AND NEVER USED BY ANY SURGEON EVER AGAIN. ITS USE ONLY DESTROYS PEOPLE LIVES JUST READ FRIDAY (B)(6) 2016 THAT THE FDA HAS FILED CHARGES AGAINST INTUITIVE SURGICAL SUPPLY FOR NOT SUBMITTING HUNDREDS OF MALFUNCTIONS TO THE FDA PRIOR TO HAVING THE DA VINCI ROBOT APPROVED. ALSO, THE FDA SAID THAT INTUITIVE SURGICAL SUPPLY CO. HAS PLACED MILLIONS OF DOLLARS IN A SPECIAL ACCOUNT TO PAY PATIENTS THAT HAVE BEEN INJURED BY THEIR DAVINCI ROBOT. PLEASE ADVISE. THE ARTICLE THAT I READ WAS IN BLOOMBERG ARTICLES CONCERNING THE DA-VINCI ROBOT. TO ACCESS THE ARTICLE, HERE IS THE WEB PAGE ADDRESS: HTTP://WWW.BLOOMBERG.COM/NEWS/ARTICLES/2016-05-26/DA-VINCI-SURGICAL-ROBOT-MAKER-FIGHTS-INSURERS-OVER-HIDDEN-CLAIMS." }, { "mdr_text_key": "241270866", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "(B)(6) RE: DA VINCI ROBOT IS A VERY DANGEROUS OPERATION DEVICE. DEAR SIR: I AM WRITING A LETTER TO YOU EXPLAINING JUST WHAT HAPPENED TO ME WHEN I WAS OPERATED ON VIA DA-VINCI ROBOT. FIRST OF ALL, MY UROLOGIST/SURGEON (MR. (B)(6)) TOLD ME AND MY FAMILY THAT I HAD DEVELOPED PROSTATE CANCER AND THAT I WOULD HAVE TO HAVE MY PROSTATE REMOVED. ON THE GLEASON SCALE READING OF 6, DR. (B)(6) SAID THAT HE RECOMMENDED USING THE DA-VINCI ROBOT BECAUSE IT WOULD DO A BETTER JOB AND THAT IT WOULD ALLOW HIM TO SEE EVERYTHING ON A BIG SCREEN SO THAT HE WOULD BE ABLE NOT TO CUT ANY NERVES OR BLOOD VESSELS THAT WOULD AFFECT ME FROM HAVING SEX AND THAT IT WOULD PREVENT ME FROM HAVING INCONTINENCE. DR. (B)(6) CONVINCED ME AND MY FAMILY THAT THE DA-VINCI ROBOT WAS THE WAY TO GO AND THAT MY FAMILY COULD PICK ME UP AT THE HOSPITAL THE NEXT MORNING. WHEN MY FAMILY CAME TO GET ME, I WAS IN A BAD WAY. I COULD NOT STAND, EAT, MOVE AND I WAS IN SO MUCH PAIN. THE NURSES HAD PUT ON ME A DRAINAGE BAG AND ABOUT EVERY TWO HOURS THE BAG WOULD FILL UP WITH BRIGHT RED BLOOD JUST LIKE IF I HAD JUST CUT MYSELF. DRAINAGE WOULD NOT BE THE SAME COLOR AS PURE BLOOD. DR. (B)(6) TOLD MY FAMILY THAT I WOULD NOT BE GOING HOME BECAUSE OF COMPLICATIONS DURING SURGERY. DR. (B)(6) SAID THAT IT HAPPENS SOMETIMES DURING ROBOTIC SURGERY. MY HOSPITAL RECORDS SHOWS THAT DURING THE FIRST WEEK IN THE HOSPITAL THE NURSES HAD GIVEN ME THREE PINTS OF WHOLE BLOOD AND TWO WEEKS LATER, THE NURSES HAD TO GIVE 3 MORE PINTS OF WHOLE BLOOD. I BECAME WEAKER AND WEAKER. I COULD NOT WALK AND I COULD NOT EAT AND I WAS MISERABLE. INSTEAD OF BEING IN THE HOSPITAL FOR ONE NIGHT, I ENDED UP BEING IN THE HOSPITAL FROM (B)(6) 2009, ALMOST A MONTH. I WAS SLOWLY BLEEDING TO DEATH INTERNALLY AND NO ONE AT THE (B)(6) (MEMORIAL) HOSPITAL HAD CAUGHT THE FACT THAT I WAS FILLING UP THE SO-CALLED DRAINAGE POUCH EVERY TWO HOURS WITH MY LIFE'S BLOOD. I WAS BLEEDING INTERNALLY AND NO ONE CAUGHT IT. ONE NIGHT ABOUT 2:00 AM MY COUSIN WAS IN MY ROOM WITH ME AND I LOOKED AT HIM AND I TOLD HIM THAT I LOVED HIM AND FOR HIM TO TELL MY FAMILY THAT I LOVED THEM. I TOLD HIM THAT I WAS DYING BECAUSE THE ROOM WAS BECOMING DARKER AND DARKER. HE TOOK OFF RUNNING TO GET A NURSE. THE NURSE CHECKED MY BLOOD PRESSURE AND IT WAS 42/36. THE NURSE IMMEDIATELY CALLED THE BLUE RESCUE TEAM TO RESITUATE ME. THE BLUE TEAM WORKED ON ME FOR OVER AN HOUR AND THEY ENDED UP GIVING ME 5 PINTS OF WHOLE BLOOD. ALL OF THE BLOOD THAT WAS IN THE DRAINAGE BAG WAS MY LIFE'S BLOOD AND THE NURSES WOULD SIMPLY WRITE DOWN HOW MUCH FLUID WAS IN THE DRAINAGE BAG AND THEN POURED THE CONTENTS DOWN THE COMMODE. THE NURSES WERE LITERALLY POURING MY LIFE'S BLOOD DOWN THE TOILET. THERE WERE TWO INTERNS THAT HELPED DR. (B)(6) WITH THE DA-VINCI ROBOTIC SURGERY ON THE REMOVAL OF MY PROSTATE. LAST YEAR I SAW ONE OF THE INTERNS THAT HAD ASSISTED WITH MY DA-VINCI SURGERY AND HIS NAME IS DR. (B)(6), AND HE HAS HIS OWN UROLOGY PRACTICE NOW. DR. (B)(6) AND I TALKED ABOUT WHAT HAD GONE WRONG DURING MY PROSTATE SURGERY USING THE DA-VINCI ROBOT. DR. (B)(6) SAID THAT DR. (B)(6) (THE DA-VINCI ROBOT SURGEON) SAID THAT HE THOUGHT THAT THEY WERE GOING TO LOSE MR.(B)(6) BECAUSE OF INTERNAL BLEEDING. DR. (B)(6) NEVER CAME TO SEE ME AFTER MY ROBOTIC SURGERY AND HE NEVER TOLD ME OR MY FAMILY WHAT WENT WRONG. ONLY HIS INTERNS CAME TO SEE ME AND THEY NEVER SAID ANYTHING ABOUT WHAT HAD GONE WRONG DURING MY ROBOTIC SURGERY. DR. (B)(6) DID NOTHING TO RECTIFY MY INTERNAL BLEEDING. DR. (B)(6) SAID THAT HE COULD TELL ME A LOT MORE, BUT HE WAS AFRAID THAT DR. (B)(6) WOULD SUE HIM. I AM NOT CERTAIN THAT DR. (B)(6) IS CERTIFIED TO PERFORM ROBOTIC SURGERY OR NOT. THE WAY THAT MY SURGERY WAS BUNGLED, MAKES ME FEEL THAT HE IS NOT QUALIFIED TO PERFORM DA-VINCI." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/27/2016" } ] }