{ "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": "2955842-2019-10876", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20191105", "manufacturer_address_2": "", "pma_pmn_number": "K173906", "date_of_event": "20190911", "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": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20191105", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1075348", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191105", "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": "380601-34", "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": "KS", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/06/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250801", "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": "20191105", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Blood Loss", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20191009", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9281382", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20191009", "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": "310980318", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN SECTIONS PMA/510K, IF FOLLOW-UP, WHAT TYPE AND ADVERSE EVENT PROBLEM. ON 11/06/2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE DA VINCI-ASSISTED SURGICAL PROCEDURE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON DOES NOT BELIEVE THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT¿S POST-OPERATIVE COMPLICATION OF INTERNAL BLEEDING RESULTING WITH A SPLENECTOMY. THE SURGEON BELIEVES THE POST-OPERATIVE COMPLICATION OCCURRED SINCE THE PATIENT WENT BACK ON BLOOD THINNERS. THE SURGEON INDICATED THAT HE DOES NOT BELIEVE THE POST-OPERATIVE COMPLICATION WOULD HAVE OCCURRED IF THE PATIENT HAD NOT BEEN ON BLOOD THINNERS. THE POST-OPERATIVE BLEED WAS IDENTIFIED 2 WEEKS AFTER THE DA VINCI-ASSISTED PROCEDURE WAS PERFORMED AND THE PATIENT WAS DISCHARGED. THE SURGEON DID NOT KNOW THE ESTIMATED BLOOD LOSS ALTHOUGH HE INDICATED THAT THE PATIENT REQUIRED A BLOOD TRANSFUSION. IN REGARDS TO THE PATIENT¿S CURRENT STATUS, THE SURGEON INDICATED THAT THE PATIENT WAS DOING WELL AND WENT HOME AS EXPECTED AFTER THE SPLENECTOMY WAS PERFORMED. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT IS NO LONGER DEEMED REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THERE IS NO EVIDENCE OR ALLEGATION THAT AN ISI DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT OR THAT AN ISI DEVICE MALFUNCTIONED IN A WAY THAT COULD CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. AFTER UNDERGOING A DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE INTERNAL BLEEDING. HOWEVER, THE SURGEON INDICATED THAT THE DA VINCI SURGICAL SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE POST-OPERATIVE COMPLICATION. THE SURGEON ATTRIBUTED THE POST-OPERATIVE BLEED TO THE USE OF BLOOD THINNERS." }, { "mdr_text_key": "165449507", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "4315 ¿ BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE PATIENT¿S POST-OPERATIVE COMPLICATION CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2019. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING: AFTER UNDERGOING AN UNEVENTFUL DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE, THE PATIENT EXPERIENCED A POST-OPERATIVE BLEED AND AS A RESULT, THE PATIENT UNDERWENT A SPLENECTOMY PROCEDURE VIA OPEN SURGERY. AT THIS TIME, THE ROOT CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO EVIDENCE THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED." }, { "mdr_text_key": "165449508", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING. AS A RESULT, THE PATIENT UNDERWENT A SPLENECTOMY VIA OPEN SURGERY ON AN UNSPECIFIED DATE. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE POST-OPERATIVE BLEEDING IS UNKNOWN. ON 10/18/2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES ASSOCIATE (CSA), AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED: THE CSA WAS NOT PRESENT DURING THE DA VINCI-ASSISTED NEPHRECTOMY. ACCORDING TO THE CSA, SHE OVERHEARD A CONVERSATION IN THE HOSPITAL REGARDING THIS PATIENT. THE PATIENT REPORTEDLY EXPERIENCED A POST-OPERATIVE BLEED THAT RESULTED WITH A SPLENECTOMY. ON 10/18/2019, ISI ALSO CONTACTED THE ISI CLINICAL TERRITORY ASSOCIATE (CTA) WHO WAS PRESENT DURING THE DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. ACCORDING TO THE CTA, THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED MALFUNCTIONS OF THE DA VINCI SURGICAL SYSTEM. THERE WERE ALSO NO INTRA-OPERATIVE COMPLICATIONS." } ], "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": "11/08/2019" } ] }