{ "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": "2955842-2013-02372", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20130701", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130510", "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", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130701", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "298373", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130701", "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 A6.0P7", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20130701", "sequence_number_treatment": [ "DA VINCI SI SURG SYS, INSTMNTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "" ], "patient_age": "56 YR", "patient_sex": "", "patient_weight": "117", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Sepsis", "Injury" ] } ], "distributor_city": "", "date_report": "20130531", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3197620", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130729", "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": "3690800", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST OP A DAVINCI SI GYNECOLOGICAL PROCEDURE, THE PATIENT EXPIRED DUE TO SEPSIS AS RESULT OF A SUSPECTED BOWEL INJURY." }, { "mdr_text_key": "10972710", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (IS) HAS CONTACTED THE HOSPITAL SEVERAL TIMES TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ON (B)(4) 2013, THE INITIAL REPORTER OF THIS COMPLAINT REPORTED THAT THIS EVENT WILL BE INVESTIGATED UNDER THE HOSPITAL'S PEER REVIEW PROCESS. AT THIS TIME THE HOSPITAL DOES NOT BELIEVE THAT THE PATIENT'S DEMISE WAS RELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORIES; HOWEVER, THIS CANNOT BE CONFIRMED, AS THE HOSPITAL HAS NOT COMPLETED THEIR INVESTIGATION. THE INITIAL REPORTER WAS UNABLE TO PROVIDE ANY FURTHER DETAILS CONCERNING THE REPORTED EVENT. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(4) 2013, THE ISI CLINICAL SALES REPRESENTATIVE FOR THE HOSPITAL SPOKE TO THE INITIAL REPORTER REGARDING THE EVENT. THE INITIAL REPORTER INDICATED TO THE CSR THAT THE PATIENT UNDERWENT A DAVINCI SI HYSTERECTOMY PROCEDURE FOR GYN ONCOLOGY. AT 13 DAYS POST OP, THE PATIENT DEVELOPED SEPSIS. THE HOSPITAL'S INTERNAL ASSESSMENT DETERMINED THAT THE COMPLICATIONS AND SUBSEQUENT DEMISE OF THE PATIENT WAS NOT RELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. NO OTHER INFORMATION WAS PROVIDED." }, { "mdr_text_key": "10919474", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED (B)(4) FROM THE HOSPITAL. THE EVENT DETAILS ARE PROVIDED BELOW: PLEASE NOTE THE 5 CASES BEING REPORTED CONCURRENTLY BY OUR FACILITY HAVE THE DAVINCI ROBOT AS A COMMONALITY; WE ARE NOT IMPLYING THAT IT IS THE CAUSE. OUR FACILITY HAS TWO DAVINCI ROBOTS. WE ARE UNCERTAIN WHICH OF THE TWO WAS USED IN THIS CASE. ON (B)(6) 2013, PT UNDERWENT A DAVINCI COMBINED TOTAL HYSTERECTOMY, SALPINGO-OOPHORECTOMY, AND NODE DISSECTION. PT ALSO HAD A LIVER BIOPSY. BY (B)(6) 2013, PT IN SEPTIC SHOCK WITH MULTI-ORGAN FAILURE. HER DRAINING ABDOMINAL WOULD CULTURED CANDIDA, CN STAPH, ANAEROBES AND DIPHTHEROIDS. SHE HAD A STAPH POSITIVE BLOOD CULTURE. SOURCE OF SEPSIS NOT CLEAR. PT WAS ON MULTIPLE GTTS TO SUPPORT HER HEMODYNAMICS AND MULTIPLE ANTIBIOTICS. PT EXPIRED IN ICU ON (B)(6) 2013. BASED ON THE ADDITIONAL INFORMATION PROVIDED IN THE SITE'S UF/IMPORTER REPORT, ISI VERIFIED THE SERIAL NUMBER OF THE DA VINCI SI SURGICAL SYSTEM THAT WAS USED TO PERFORM THE SURGICAL PROCEDURE. ON (B)(4) 2013, ISI CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE SURGEON REPORTED THAT THE PATIENT WAS SUPER MORBIDLY OBESE WITH MULTIPLE MEDICAL PROBLEMS, INCLUDING CIRRHOSIS. THE SURGEON STATED THAT THE PATIENT RETURNED TO THE HOSPITAL APPROXIMATELY 3 DAYS POST-OPERATIVELY WITH SEPSIS. AN EXPLORATORY PROCEDURE FOUND NO CAUSE FOR SEPSIS, AS THERE WAS NO PUS OR BOWEL PERFORATION FOUND. THE PATIENT DEVELOPED MULTI-SYSTEM ORGAN FAILURE AND DIED. THE SURGEON INDICATED THAT IT WAS HIS BELIEF THAT THE PATIENT'S DEMISE WAS DUE TO CIRRHOSIS. THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, NO MALPRACTICE, AND NO USE/TRAINING ISSUES RELATED TO THE REPORTED EVENT. 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 POST-SURGICAL COMPLICATIONS EXPERIENCED BY 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": "08/28/2013" } ] }