{ "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": "2955842-2025-19327", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250508", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250107", "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": "TW", "manufacturer_contact_area_code": "408", "date_added": "20250508", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20241008", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "268657", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250508", "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": "380601-51", "catalog_number": "N/A", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/21/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250826", "health_professional": "Y", "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": "20250508", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Pleural Effusion", "Respiratory Tract Infection", "Respiratory Acidosis", "Unspecified Respiratory Problem", "Pleural Effusion", "Respiratory Tract Infection", "Respiratory Acidosis", "Unspecified Respiratory Problem" ] } ], "distributor_city": "", "date_report": "20250416", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21985509", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250422", "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": "369831346", "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. A SYSTEM LOG REVIEW COULD NOT BE PERFORMED BECAUSE REMOTE SYSTEM LOGS WERE NOT AVAILABLE." }, { "mdr_text_key": "369831347", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI ASSISTED RADICAL NEPHROURETERECTOMY AND BLADDER CUFF RESECTION SURGICAL PROCEDURE. THE NEXT DAY, THE PATIENT EXPERIENCED DIFFICULTY BREATHING. UPON PHYSICAL EXAMINATION, NO WHEEZING, NO SOFT ABDOMEN, AND THE PATIENT WAS BREATHING RAPIDLY, REQUIRING THE USE OF A NON-REBREATHER MASK (NRM). IT WAS OBSERVED THAT THE PATIENT WAS USING ACCESSORY MUSCLES AND CONTINUED TO BREATHE RAPIDLY. ARTERIAL BLOOD GAS ANALYSIS SHOWED CARBON DIOXIDE RETENTION AND REDUCED PARTIAL PRESSURE OF OXYGEN (PO2). DUE TO DIFFICULTIES IN INTUBATION, AN ANESTHESIOLOGIST WAS CONSULTED TO PERFORM INTUBATION. A CT SCAN OF THE CHEST, ABDOMEN, AND PELVIS WITH AND WITHOUT CONTRAST WAS CONDUCTED. A SMALL PULMONARY EMBOLISM COULD NOT BE RULED OUT, AND THE PATIENT DEVELOPED A FEVER OF 38.8 DEGREES CELSIUS. THE PATIENT WAS TRANSFERRED TO THE ICU FOR FURTHER CARE. UPON VERBAL CONVERSATION WITH STUDY TEAM, ALL SYMPTOMS WERE RELIEVED, AND THE PATIENT WAS DISCHARGED WITH NO FURTHER COMPLICATION. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION DURING THE PROCEDURE. THE STUDY INVESTIGATOR REPORTED THAT THE EVENT WAS UNLIKELY TO BE RELATED TO THE DA VINCI SP DEVICE AND UNLIKELY TO BE RELATED TO THE PROCEDURE AND RESPONDED TO FOLLOW-UP THAT A DA VINCI DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT." }, { "mdr_text_key": "372006487", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "372006488", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE QUERY SUGGESTS THAT THE HIGH FEVER MAY BE CAUSED BY PNEUMONIA AND PLEURAL EFFUSION IN THE RIGHT LOWER LOBE. SUBSEQUENT IMAGING AND DIAGNOSTIC TESTS, INCLUDING SPUTUM CULTURE AND CHEST X-RAY, HAVE CLEARLY INDICATED SIGNS OF INFECTION. AFTER DISCUSSING WITH THE FAMILY, THE PATIENT WAS INTUBATED AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR CARE. DURING THE ICU STAY, THE PATIENT WAS TREATED WITH STEROIDS, ANTIBIOTICS, AND ANTICOAGULANTS, AND RECEIVED ETT (ENDOTRACHEAL TUBE) PLUS MECHANICAL VENTILATION FOR 18 DAYS. THE PATIENT WAS TRANSFERRED TO A GENERAL WARD THE DAY AFTER EXTUBATION AND DISCHARGED 3 DAYS LATER. THE ORIGINALLY PLANNED FIVE-DAY HOSPITAL STAY WAS EXTENDED BY AN ADDITIONAL 19 DAYS. THE PATIENT WAS HOSPITALIZED FOR A TOTAL OF 26 DAYS (INCLUDING THE SURGERY DAY)." } ], "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": "06/09/2025" } ] }