{ "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": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2013-00116", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20130110", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20101217", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20130111", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "13818", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130110", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "DA VINCI S", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000", "catalog_number": "IS2000", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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", "Appropriate Device Problem Term/Code Not Available" ], "reporter_state_code": "AZ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;03/05/2025", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "US", "date_changed": "20250822", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20130110", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES.", " DA VINCI SURG SYSTEM INSTRUMENTS AND ACCESSORIES.", " NA.", " NA.", " DA VINCI SURG SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention", " O" ], "patient_age": "31 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Abscess", "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Unspecified Infection", "Septic Shock", "Septic Shock", "Distress", "Distress", "Burn, Thermal", "Burn, Thermal" ] } ], "distributor_city": "", "date_report": "20250305", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "2909077", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20130528", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "3063878", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ACCORDING TO ALLEGATIONS MADE IN A LAWSUIT, THE PATIENT EXPERIENCED INTRA-ABDOMINAL BLEEDING, THERMAL BURNING, SEVERE INFECTION WITH INTRA-ABDOMINAL ABSCESSES, AND SEPTIC SHOCK AFTER A DA VINCI HYSTERECTOMY PROCEDURE. THE PATIENT CONTINUES TO SUFFER FROM CHRONIC ABDOMINAL PAIN AND SEVERE BOWEL ISSUES. THE PATIENT HAS BEEN UNABLE TO MAINTAIN INTIMATE RELATIONSHIPS AND SUFFERS EMOTIONAL DISTRESS. ALLEGEDLY, THE PATIENT UNDERWENT MULTIPLE ADDITIONAL MEDICAL TESTS/PROCEDURES AND SURGERY." }, { "mdr_text_key": "10942772", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT." }, { "mdr_text_key": "10450343", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO PATIENT OR HOSPITAL NAME/CONTACT INFORMATION PROVIDED FOR THE REPORTED EVENT. THEREFORE, A FOLLOW UP ON THE ALLEGED PATIENT'S CONDITION AND EVENT DESCRIPTION COULD NOT BE MADE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/08/2013;03/10/2025" } ] }