{ "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": "MW5068091", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20170222", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20070120", "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": "20170224", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "134046", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170222", "brand_name": "DA VINCI ROBOTICS", "generic_name": "COMPUTER CONTROLLED SURGICAL INSTRUMENT", "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": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "WV", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250805", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20170222", "sequence_number_treatment": [ "EFFEXOR", " OTC MEDS: ONE A DAY VITAMIN", " RX MEDS: XANAX" ], "sequence_number_outcome": [ "Hospitalization", " L", " O" ], "patient_age": "75 YR", "patient_sex": "", "patient_weight": "90", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Blood Loss", "Pain", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20170222", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6356231", "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": "68395091", "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)(4)) TOLD ME AND MY FAMILY THAT I HAD DEVELOPED PROSTATE CANCER AND THAT I WOULD HAVE TO HAVE MY PROSTATE REMOVED BECAUSE ON THE GLEANSON 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, UNTIL (B)(6) 2009, ALMOST A MONTH. I WAS SLOWLY BLEEDING TO DEATH INTERNALLY AND NO ONE AT THE (B)(6) 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 ME FAMILY THAT I LOVED THEM. I TOLD HIM 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), DO 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": "" } ] }