{ "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": "2955842-2014-01218", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140303", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20111018", "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": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140303", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "126506", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140303", "brand_name": "DA VINCI S 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": "IS2000 A5.1P8", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "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": "20140303", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stroke/CVA", "Death", "Fever", "Unspecified Infection" ] } ], "distributor_city": "", "date_report": "20140131", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3654260", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140131", "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": "4318418", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI BOWEL SURGERY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT SUFFERED A SEVERE INFECTION WHICH RESULTED IN A SECOND HOSPITALIZATION, A HIGH TEMPERATURE, WHICH LEAD TO A STROKE AND HER PASSING AWAY. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND DISCHARGE SUMMARY. BASED ON THE OPERATIVE REPORT, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THERE WAS ALSO NO INDICATION THAT AN INTRA-OPERATIVE COMPLICATION OCCURRED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION AFTER COMPLETION OF THE SURGICAL PROCEDURE. THE PATIENT WAS DISCHARGED HOME ON POST-OPERATIVE DAY 1 ((B)(6) 2011). ACCORDING TO THE DISCHARGE SUMMARY, THE OPERATIVE AND POST OPERATIVE COURSE WAS UNCOMPLICATED. ON (B)(4) 2014, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT FROM THE SITE. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT AND CONFIRMED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED. THE RISK MANAGER ALSO DID NOT FIND ANY ADDITIONAL PATIENT RECORDS AFTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. THE RISK MANAGER COULD NOT CONFIRM THAT THE PATIENT DEVELOPED AN INFECTION, WAS HOSPITALIZED, SUFFERED A STROKE, AND PASSED AWAY." }, { "mdr_text_key": "11705175", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE DATE OF THE PATIENT'S DEATH IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2011. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL DOCUMENT CLAIMS THAT THE PATIENT DEVELOPED A SEVERE INFECTION, DEVELOPED A HIGH TEMPERATURE, SUFFERED A STROKE, AND PASSED AWAY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S REPORTED POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE ARE UNKNOWN." } ], "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": "" } ] }