{ "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": "MW5058544", "type_of_report": [ "" ], "product_problem_flag": "N", "date_received": "20151212", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20140505", "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": "20151216", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "821258", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20151212", "brand_name": "DA VINCI ROBOT", "generic_name": "DA VINCI ROBOT", "manufacturer_d_name": "INTUITIVE", "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 answer provided", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20151212", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " O", " R", " S" ], "patient_age": "42 YR", "patient_sex": "", "patient_weight": "99", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Incontinence", "Unspecified Infection", "Nausea", "Pain", "Scar Tissue", "Sepsis", "Skin Discoloration", "Swelling", "Complaint, Ill-Defined" ] } ], "distributor_city": "", "date_report": "20151212", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5303455", "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": "33752290", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MY GYNECOLOGIST RECOMMENDED THE DA VINCI TO ME. SHE SAID IT WAS THE WAY TO GO. ON (B)(6) 2014, I HAD MY PLANNED SURGERY BUT I NEVER RECOVERED. I WAS NAUSEATED THE FIRST WEEK ((B)(6) BACK TO WORK, SO I HAD CALLED AND ASKED FOR SOMETHING TO CONTROL THE NAUSEA. I HAD NO BLADDER CONTROL BEGINNING (B)(6). I HAD A WETTING ACCIDENT AT WORK. I THOUGHT I HAD A BAD UTI. I KEPT CALLING MY DR'S OFFICE AND FINALLY GOT IN TO SEE HER AND SHE REFERRED ME THE SAME DAY TO A UROLOGIST. I HAD TO WEAR ADULT DIAPERS SINCE (B)(6). ON (B)(6) 2014 MET WITH A UROLOGIST ON A FRIDAY, AND HE TOLD ME THAT HE NEEDED TO SEE ME IN THE OPERATING ROOM ON THE FOLLOWING MONDAY TO PLACE A STENT IN. THE RIGHT URETER HAD STOPPED WORKING. ON (B)(6) 2014 THE STENT WAS REMOVED. SIX DAYS LATER, (B)(6) 2014, I FELL ILL AT WORK. MY STOMACH HAD SWELLED AND I COULD HEAR WATER GUSHING THROUGH MY STOMACH. I CALLED MY DOCTOR. HE SAID GO GET MRI AT THE HOSPITAL AND BRING HIM THE DVD. I WAS IN HIS OFFICE AT 1:30 AND HE SAID I NEED TO SEE YOU IN THE OPERATING ROOM AT 2:00. I HAD FLUID BACKING UP IN THE RIGHT KIDNEY. ON (B)(6), DR (B)(6) REPLACED THE STENT. ON (B)(6) 2014, I WENT TO (B)(6) FOR A SECOND OPINION. THE DOCTOR THERE SAID \"YOUR DOCTOR IN (B)(6) IS DOING EVERYTHING THAT I WOULD HAVE DONE AND HE IS REQUESTING ALL OF THE TESTS THAT I WOULD HAVE REQUESTED.\" ON (B)(6) 2014, I HAD A PYELOGRAM TEST SCHEDULED IN THE OPERATING ROOM. AFTERWARDS, MY DOCTOR TOLD ME THAT HE COULDN'T GET THE DYE PAST WHERE HE NEEDED IT TO. ON (B)(6) 2014, I MET WITH MY DOCTOR. HE TOLD ME THAT \"I HAVE DONE ALL THAT I COULD DO TO GET USE THE DA VINCI BECAUSE THAT'S HOW YOU ENDED UP HERE, NOT SAYING THAT THE DA VINCI IS NOT A GOOD MACHINE.\" ON (B)(6) 2014, I HAD MY SURGERY. NOTHING COULD HAVE PREPARED ME FOR IT. I WAS SO SICK. I WAS TOLD THAT THEY HAD TO MOVE SOME OF THE ORGANS ON MY RIGHT TO REPAIR ME. I LOST MY SKIN COLOR, AND I TRULY THOUGHT I WAS GOING TO DIE. I ENDED UP BACK IN THE HOSPITAL FOR A WEEK AFTER, FOR SEVERAL DAYS, WITH A SEPSIS INFECTION. I COULDN'T DO ANYTHING FOR MYSELF. I WAS OUT OF WORK ALL MONTH. I HAVE A LONG UGLY SCAR FROM THE BIKINI LINE UP AROUND PAST MY NAVEL. MY URETER IS SHORTER ON THE RIGHT SIDE. I SUFFER FROM BACK PAIN AND PAIN IN MY SIDE BECAUSE OF THE SHORTER URETER. I HAVE MORE INTENSE PAIN ON THAT SIDE. AS A RESULT OF USING THE DA VINCI ROBOT, I WILL REQUIRE LIFELONG MEDICAL CARE. NOW I HAVE TO WORRY ABOUT SCAR TISSUE ON MY URETER. I DON'T DRINK ON LONG TRIPS BECAUSE THE URGE TO GO IS SO STRONG THAT I WILL HAVE AN ACCIDENT. I AM ONLY (B)(6). MY INSURANCE HAS PAID OUT OVER $(B)(6) AND I STILL HAVE APPOINTMENTS FOR THE NEXT TWO WEEKS FOR AN ULTRASOUND AND TO MEET WITH THE UROLOGIST WHO PERFORMED THE REPAIR. I HAVE MISSED 196.50 HOURS FROM WORK. I DEVELOPED A SEPSIS INFECTION. I AM SO HURT BECAUSE I HAVE BEEN LEFT OUT HERE ALONE. NO ONE CARES. I ALMOST DIED." } ], "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": "" } ] }