{ "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": "2955842-2024-13706", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240430", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240401", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20240430", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210721", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "146556", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240430", "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": "380601-44", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Appropriate Device Problem Term/Code Not Available", "Appropriate Device Problem Term/Code Not Available" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250728", "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": "20240430", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20240402", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19210626", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240402", "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": "341353677", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE PHYSICIAN ATTRIBUTED THE UNCONTROLLED BLEEDING AND SEQUELA OF EVENTS TO THE THIRD-PARTY INSTRUMENT. THERE WAS NO ALLEGATION OF DA VINCI SYSTEM OR INSTRUMENT MALFUNCTION ASSOCIATED WITH THE EVENT. A REVIEW OF THE SITE'S SYSTEM LOGS FOUND THAT NO RELATED SYSTEM ERRORS OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AN ADVANCED SYSTEM STREAMING LOG REVIEW FOUND NO ABNORMALITIES OR EVENTS THAT WOULD SUGGEST ANY FAULT WITH THE SYSTEM." }, { "mdr_text_key": "341353678", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT HAD A LOT OF BLEEDING. THE PROCEDURE WAS ABORTED AND CONVERTED TO OPEN SURGERY. DURING THE PROCEDURE, A THIRD-PARTY GOLD SCANLAN BULLDOG CLAMP WAS USED VIA A SEPARATE PORT SITE. THE USE OF THE SCANLAN BULLDOG CLAMP WAS A REQUIRED STEP FOR THE PROCEDURE, THIS WAS USED TO CLAMP THE RENAL ARTERY. THE SURGEON REPORTED THAT THE SCANLAN BULLDOG CLAMP DID NOT HAVE A STRONG ENOUGH GRIP TO CLAMP THE PATIENT'S STIFF RENAL ARTERY WHICH CAUSED A LOT OF BLEEDING. THE BLEEDING COULD NOT BE CONTROLLED, AND THE PROCEDURE WAS CONVERTED TO OPEN. THE PATIENT WAS REPORTED TO BE STABLE AND REMAINS HOSPITALIZED. THE SURGEON REPORTED THAT THERE WAS NOT AN ISSUE WITH THE SINGLE PORT PLATFORM BUT RATHER, WITH THE THIRD-PARTY INSTRUMENTATION CLAMPING PRESSURE." } ], "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": "" } ] }