{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2019-10375", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190523", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20160322", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190523", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "428313", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190523", "brand_name": "DA VINCI", "generic_name": "DA VINCI SURGICAL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/15/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20190523", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Urinary Tract Infection", "Injury", "Pain", "Urinary Tract Infection", "Injury" ] } ], "distributor_city": "", "date_report": "20190515", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8637856", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190515", "manufacturer_name": "", "report_source_code": "Manufacturer 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": "175489040", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "CORRECTED DATA - THE INITIAL MDR WAS SUBMITTED ON 05/23/2019 WITH THE INCORRECT (TYPE OF REPORT) VALUE OF \"5-DAY.\" THE CORRECT VALUE FOR THE INITIAL MDR SHOULD BE \"INITIAL\" AND \"30-DAY,\" NOT \"5-DAY.\"" }, { "mdr_text_key": "146216538", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF¿S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED A SEVERED URETER WHILE UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE AND HAD TO VISIT A HOSPITAL FREQUENTLY AFTER DEVELOPING POST-OPERATIVE SYMPTOMS. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT¿S ALLEGED OPERATIVE COMPLICATIONS ARE UNKNOWN." }, { "mdr_text_key": "146216539", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO REPORTEDLY UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE ON (B)(6) 2016. THE PLAINTIFFS¿ ATTORNEY ALLEGES THAT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT¿S LEFT URETER WAS SEVERED. AS A RESULT, THE PLAINTIFF¿S ATTORNEY CLAIMS THAT THE PATIENT HAS SUFFERED CHRONIC URINARY TRACT INFECTIONS, BLADDER LEAKAGE, PAIN, AND OTHER UNSPECIFIED PROBLEMS. IN ADDITION, THE PATIENT HAS REPORTEDLY BEEN A FREQUENT PATIENT AT HOSPITALS SINCE THE SURGERY TO ATTEMPT TO CORRECT HER PROBLEMS. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT¿S MEDICAL RECORDS." } ], "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": "05/24/2019" } ] }