{ "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": "", "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": "2955842-2026-04235", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260213", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260121", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20260213", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240426", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "399015", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260213", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "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": "380601-50", "catalog_number": "380601", "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": "00886874114605", "udi_public": "(01)00886874114605", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/18/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260504", "health_professional": "Y", "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": "20260213", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "64 YR", "patient_sex": "Female", "patient_weight": "71 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Fever", "Unspecified Infection" ] } ], "distributor_city": "", "date_report": "20260409", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24337532", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260121", "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": "398484975", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "398484976", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE ADVERSE EVENT DESCRIBED IS NOT UNIQUE TO AN ISI PRODUCT AND THE ISI PRODUCT COULD NOT HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT; HOWEVER, THERE IS A PROBABLE RELATIONSHIP TO THE STUDY PROCEDURE. PER THE MSO, \"THE PATIENT IN THIS REPORT DEVELOPED AN INFECTION REQUIRING ANTIBIOTICS WHICH RESOLVED AFTER A SHORT COURSE OF THERAPY. THE SOURCE OF THE INFECTION WAS NOT REPORTED. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, THIS COMPLICATION WAS MOST LIKELY RELATED TO THE PROCEDURE ALTHOUGH THIS PATIENT¿S MULTIPLE PRIOR PROCEDURES AND COMORBIDITIES MAY HAVE BEEN CONTRIBUTING FACTORS. THERE IS NO EVIDENCE THIS COMPLICATION WAS RELATED TO THE STUDY DEVICE.\"" }, { "mdr_text_key": "393118475", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. ADDITIONAL PATIENT INFORMATION: HEIGHT 172 CM.; BODY MASS INDEX (BMI) 24.0 KG/M2." }, { "mdr_text_key": "393118476", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED PELVIC AND PARAAORTIC LYMPHADENECTOMY PROCEDURE. ONE WEEK AFTER THE INDEX PROCEDURE, A POST-DISCHARGE INFECTION WITH FEVER AND LOWER ABDOMINAL PAIN WAS REPORTED REQUIRING AN UNSPECIFIED ANTIBIOTIC AND REHOSPITALIZATION FOR ONE WEEK, AT ANOTHER HOSPITAL. THE EVENT WAS REPORTED AS RESOLVED ONE WEEK LATER. THE INDEX PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED ADVERSE EVENTS, OR INJURIES. NO MALFUNCTIONS INVOLVING THE DA VINCI SYSTEM, ITS ACCESSORIES, OR ITS INSTRUMENTS WERE REPORTED. DISCHARGE OCCURRED ON AN UNSPECIFIED DATE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS SEVERE, A SERIOUS ADVERSE EVENT (REQUIRING MEDICAL OR SURGICAL INTERVENTION), A CLAVIEN-DINDO GRADE II, HAVING A PROBABLE RELATIONSHIP TO THE STUDY PROCEDURE, BUT NOT RELATED TO THE DA VINCI INVESTIGATIONAL DEVICE, NOT RELATED TO A THIRD-PARTY DEVICE, AND NOT RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/10/2026" } ] }