{ "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": "2955842-2013-04653", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131025", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20131007", "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": "20131028", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "548336", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131025", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250825", "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": "20131025", "sequence_number_treatment": [ "DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "Death" ] } ], "distributor_city": "", "date_report": "20131008", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3430606", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131008", "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": "11341638", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S DEMISE. AT THIS TIME, THERE HAS BEEN NO REPORT THAT A MALFUNCTION OF THE DA VINCI S SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) ASSIGNED TO THE SITE. THE CSR INDICATED THAT HE SPOKE TO THE SURGEON AND A NURSE WHO WAS PRESENT DURING THE PROCEDURE A DAY AFTER THE EVENT OCCURRED. ACCORDING TO THE CSR, THE SURGEON AND NURSE DID NOT REPORT THAT A MALFUNCTION OF THE DA VINCI S SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR ALSO INDICATED THAT THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS BEFORE THE PATIENT CODED. THE CSR DID NOT KNOW THE CAUSE OF THE PATIENT'S DEMISE. ON (B)(6) 2013, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT AT THE SITE. THE RISK MANAGER INDICATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE RISK MANAGER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ISI HAS ATTEMPTED TO CONTACT THE SURGEON INVOLVED WITH THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE SURGEON AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CODED DURING VAGINAL CUFF CLOSURE OF A DA VINCI S HYSTERECTOMY PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN." }, { "mdr_text_key": "3854749", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE PATIENT CODED DURING VAGINAL CUFF CLOSURE. AT THE TIME THE PATIENT CODED, THE INITIAL REPORTER INDICATED THAT THE DA VINCI S SURGICAL SYSTEM WAS UNDOCKED FROM THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL STAFF WAS UNABLE TO REVIVE THE PATIENT WHO SUBSEQUENTLY PASSED AWAY." } ], "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": "" } ] }