{ "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": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2955842-2014-05112", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140821", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140619", "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 representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140821", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "506869", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140821", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "KS", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20140821", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20140722", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4027841", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140722", "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": "4801848", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI PARTIAL NEPHRECTOMY PROCEDURE, THE SURGEON ENCOUNTERED HEAVY BLEEDING FROM THE PATIENT AND DUE TO THE EXTENSIVE BLEEDING EXPERIENCED BY THE PATIENT THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUES. LATER THAT NIGHT, THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM (OR) AND A VASCULAR SURGEON WAS CONSULTED. ACCORDING TO THE SURGEON IT IS THE HOSPITAL'S BELIEF THAT THE PATIENT'S AORTA HAD BEEN NEARLY STAPLED ACROSS. THE PATIENT EXPIRED IN THE OR. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT REGARDING THE REPORTED EVENT. ACCORDING TO THE SITE'S RISK MANAGER, THE HOSPITAL'S INVESTIGATION IS ONGOING; HOWEVER, THEIR INVESTIGATION THUS FAR HAS DETERMINED THAT THE INTRA-OPERATIVE BLEEDING EXPERIENCED BY THE PATIENT AND FINAL PATIENT OUTCOME WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. THE RISK MANAGER INDICATED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE PLANNED SURGICAL PROCEDURE. THE RISK MANAGER INDICATED THAT HE WAS UNABLE TO PROVIDE ANY OTHER DETAILS REGARDING THE REPORTED EVENT AND REITERATED THAT THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES IN NO WAY CAUSED OR CONTRIBUTED TO THE INCIDENT." }, { "mdr_text_key": "12263649", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT EXPERIENCE INTRA-OPERATIVE BLEEDING THAT REQUIRED CONVERSION TO AN OPEN PROCEDURE. POST-OPERATIVELY THE PATIENT EXPERIENCED COMPLICATIONS AND SUBSEQUENTLY EXPIRED. BASED ON THE INFORMATION PROVIDED BY THE SITE, THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DID NOT CAUSE OR CONTRIBUTE TO THE INTRA-OPERATIVE BLEEDING AND SUBSEQUENT DEMISE OF THE PATIENT." } ], "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": "" } ] }