{ "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": "MW5063911", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20160804", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20090202", "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": "20160809", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "500366", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160804", "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": "", "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": [ "Appropriate Device Problem Term/Code Not Available" ], "reporter_state_code": "WV", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20160804", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " O", " S" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "90", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Nausea", "Pain", "Complaint, Ill-Defined", "Hemorrhage/Blood Loss/Bleeding", "Nausea", "Pain", "Complaint, Ill-Defined" ] } ], "distributor_city": "", "date_report": "20160804", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5856071", "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": "51720203", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "I WAS TOLD BY THE SURGEON THAT I HAD PROSTATE CANCER AND HE SUGGESTED THE DA VINCI ROBOT. HE SAID THAT I WOULD NOT EVEN KNOW THAT I HAD BEEN OPERATED ON AND THAT I WOULD LEAVE THE HOSPITAL THE NEXT DAY. HOWEVER, I REMAINED A PT IN THE HOSPITAL FOR 33 DAYS, I WAS BLEEDING INTERNALLY AND I WAS GIVEN 18 PINTS OF BLOOD. I LOST OVER 45 LBS AND I COULD NOT WALK, EAT, OR DRINK ANYTHING BY MYSELF. I WAS FINALLY RELEASED AFTER 33 DAYS IN THE HOSPITAL AND 12 HOURS AFTER I WAS DISCHARGED, I HAD TO BE READMITTED BECAUSE OF PAIN, BLEEDING AND NAUSEA. SINCE THE DA VINCI SURGERY, I HAVE HAD TO HAVE SEVEN MORE OPERATIONS. THE SURGEON THAT PERFORMED THE ORIGINAL DA VINCI ROBOTIC SURGERY NEVER EVER CAME TO SEE ME OR TO CHECK ON ME WHILE I WAS HOSPITALIZED FOR APPROX 5 WEEKS." } ], "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": "" } ] }